Abstract
Purpose
To evaluate the long-term efficacy of aflibercept using a treat-and-extend (T&E) protocol in Chinese patients with neovascular age-related macular degeneration (nAMD) and to explore baseline imaging predictors of treatment response.
Methods
This retrospective, real-world study included patients with treatment-naïve nAMD who received intravitreal aflibercept (2.0 mg) under a T&E regimen for 24 months. Best-corrected visual acuity (BCVA), central macular thickness (CMT), and OCT-derived structural features were assessed. Patients were stratified into effective and non-effective groups based on visual outcomes at 24 months.
Results
A total of 37 eyes were included. Compared with baseline (0.71±0.48 logMAR), BCVA improved significantly at 3 months (0.58±0.50, p=0.029), 6 months (0.51±0.32, p<0.01), and remained improved at 24 months (0.57±0.44, p=0.002). Mean ΔBCVA at 24 months was −0.15±0.27 logMAR. CMT decreased from 409.89±219.24 μm at baseline to 277.43±113.92 μm at 3 months (p<0.001), with sustained reductions throughout follow-up (ΔCMT −145.71±239.50 μm at 24 months). Subretinal fluid (SRF), intraretinal fluid (IRF), and pigment epithelial detachment height (PEDH), resolved significantly during follow-up (all p ≤ 0.05), whereas hyperreflective dots (HRD), subretinal hyperreflective exudation (SHE), fibrosis, and macular atrophy (MA) tended to increase progressively. In subgroup analysis, the effective group showed higher baseline CMT (473 vs 293 μm, p=0.015), more frequent SRF (70.8% vs 30.8%, p=0.019), and more HRD (79.2% vs 46.2%, p=0.041). Multivariate logistic regression confirmed higher baseline CMT (OR=1.01, p=0.030) and SRF presence (OR=5.40, p=0.028) as independent predictors of visual response.
Conclusion
Intravitreal aflibercept administered under a T&E regimen provides sustained visual and anatomical benefits in Chinese patients with nAMD. Baseline OCT features, particularly CMT and SRF, are valuable predictors of treatment efficacy, supporting their role in individualized therapeutic decision-making.
Keywords: aflibercept, neovascular age-related macular degeneration, treat-and-extend, OCT biomarkers, real-world study
Introduction
Neovascular age-related macular degeneration (nAMD) is a leading cause of irreversible vision loss in the elderly population worldwide, including in China, where the aging demographic has resulted in a rapidly increasing disease burden.1,2 The introduction of intravitreal anti-vascular endothelial growth factor (VEGF) agents has revolutionized nAMD treatment, significantly improving visual outcomes and preserving quality of life.3,4 Of which, aflibercept, a recombinant fusion protein that binds VEGF-A, VEGF-B, and placental growth factor, has shown robust efficacy and durability in both randomized clinical trials and real-world practice.5
Various dosing regimens have been developed to balance efficacy, safety, and treatment burden, with the treat-and-extend (T&E) protocol gaining increasing attention. The T&E approach individualizes retreatment intervals based on disease activity, aiming to maintain optimal visual and anatomical outcomes while reducing the frequency of clinic visits and injections. While evidence from clinical trials supports the effectiveness of aflibercept under T&E regimens, data from real-world settings, particularly in Asian populations, remain limited.
In addition to visual acuity and central macular thickness (CMT), advances in optical coherence tomography (OCT) have enabled more precise monitoring of disease activity, including evaluation of intraretinal fluid (IRF), subretinal fluid (SRF), pigment epithelial detachment (PED), and other structural biomarkers.6–9 These imaging features may influence treatment response and long-term outcomes, yet their role in predicting efficacy under T&E regimens in routine clinical practice requires further investigation. Moreover, the evidence of treatment response of T&E regimens among Chinese is still limited.
Herein, the present study aimed to evaluate the real-world effectiveness of intravitreal aflibercept 2 mg using a T&E protocol in Chinese patients with nAMD over a 24-month period. The primary endpoints were changes in best-corrected visual acuity (BCVA) and CMT, together with OCT-based morphological changes. Secondary analyses explored the impact of baseline and dynamic OCT imaging biomarkers on treatment response, with patients stratified into effective and non-effective groups according to BCVA outcomes. This study was all reported in accordance with the STROCSS guidelines.10
Methods
Study Population
This study was designed as a retrospective, single-arm, observational analysis. Eligible participants were patients aged 50 years or older who were newly diagnosed with nAMD between 08/2022 and 06/2023. Written informed consents were obtained from all participants before initiating treatment. The diagnosis was established based on fundus fluorescein angiography (FFA) and/or optical coherence tomography angiography (OCTA).11 The project was conducted in accordance with the Declaration of Helsinki. Clinical trial registration number is ChiCTR2400090054.
Inclusion and Exclusion
All patients had received intravitreal aflibercept 2 mg (EYLEA®, Vetter Pharma-Fertigung GmbH & Co. KG) as their initial anti-VEGF therapy and completed at least 24 months of follow-up. Patients were excluded if they had received prior anti-VEGF or photodynamic therapy, if other retinal diseases such as diabetic retinopathy, retinal vein occlusion, or pathological myopia were present, or if they had undergone ocular surgery other than uncomplicated cataract extraction within the preceding six months. Eyes with media opacities or poor-quality OCT images that prevented reliable assessment were also excluded.
Surgery Methods
Following thorough irrigation of the conjunctival fornix, one drop of Proparacaine hydrochloride solution (Alcon, USA) is instilled every five minutes for three cycles. After standard sterile draping, the cul-de-sac is bathed with 5% povidone-iodine (Liercon, Shandong) for 90 seconds. A 30-gauge needle is then introduced 3.5–4 mm posterior to the limbus to deliver 2 mg aflibercept in 0.05 mL into the vitreous; needle removal is followed immediately by light-perception verification. Postoperatively, all patients receive levofloxacin 0.5% eye drops (Cravit, Santen) q.i.d. for one week. All intravitreal aflibercept injections were performed by vitreoretinal subspecialists who had completed a structured hospital-approved training pathway. No complications occurred.
Treatment Protocol
All patients initially underwent three consecutive monthly intravitreal aflibercept (IVA, 2 mg/0.05 mL), after which treatment was guided by a T&E protocol.12 Under this regimen, if no intraretinal or subretinal fluid or hemorrhage was detected by fundus examination or OCT, the interval between visits was lengthened in two-week increments, up to a maximum of 16 weeks. Conversely, if disease activity was evident, defined as recurrent retinal fluid, hemorrhage, or vision decline associated with anatomical changes, the interval was shortened by two weeks. When a patient successfully completed three consecutive 16-week treatment intervals without recurrence, therapy was suspended and the patient was transitioned to a monitoring phase. During monitoring, follow-up visits were scheduled every 16 weeks, and if disease recurrence was identified, the visit interval was shortened by two weeks.
Ophthalmologic Examinations
At each scheduled visit, all participants underwent a standardized ophthalmic evaluation. The examination protocol included BCVA, slit-lamp biomicroscopy, dilated fundus examination, color fundus photography, and spectral-domain SD-OCT (Heidelberg Engineering GmbH, Spec-TR-04283). BCVA was assessed using a standardized Landolt C chart and converted to the logarithm of the minimum angle of resolution (logMAR) for analysis. CMT, IRF, SRF, and PED was derived from SD-OCT B-scans images as the mean retinal thickness within the central 1-mm Early Treatment Diabetic Retinopathy Study (ETDRS) subfield. A single experienced retina specialist performed all OCT assessments.
Baseline multimodal imaging, including fluorescein angiography (FA) and indocyanine green angiography (ICGA), was performed to confirm diagnosis and characterize lesion morphology. The eyes were classified based on the change of ETDRS letters, with a gain of five ETDRS letters or more denoted as “improved” (effective group), and the opposite as “declined” (non-effective group) at months 24.
Outcomes
The primary study outcomes were the mean changes in BCVA and CMT from baseline to months 24. Secondary outcomes included morphological changes on OCT, such as intraretinal fluid, subretinal fluid, and pigment epithelial detachment and visits recorded during the 24-month follow-up. To further explore predictors of treatment response, patients were categorized into effective and non-effective groups according to their visual outcomes at month 24, with an effective response defined as a gain of at least five ETDRS letters. Baseline and dynamic OCT biomarkers were then compared between the two groups.
Statistical Analysis
All statistical analyses were performed using SPSS version 26.0 (IBM Corp., Armonk, NY, USA). Continuous variables were expressed as mean ± standard deviation (SD) or median with interquartile range (IQR), and categorical variables were presented as counts and percentages. Comparisons of BCVA and CMT from baseline to follow-up time points were performed using paired t-tests or Wilcoxon signed-rank tests as appropriate. Between-group differences were assessed using independent-samples t-tests, chi-square tests, or Fisher’s exact tests. Logistic regression analyses were applied to identify imaging biomarkers associated with treatment efficacy. A two-sided P-value less than 0.05 was considered statistically significant.
Results
Overall Changes in BCVA, CMT, and OCT Parameters
There were 37 participants [23 (62.16%) females] with nAMD included in this study. The mean age was 72.92±7.25 years old.
In the overall cohort, BCVA improved significantly after aflibercept treatment under the T&E protocol (P<0.001). Compared with baseline (0.71±0.48 logMAR), BCVA showed significant gains at 3 months (0.58±0.50, p=0.029), 6 months (0.51±0.32, p<0.01), 12 months (0.57±0.46, p=0.006), and 24 months (0.57±0.44, p=0.002), although the improvement at 18 months did not reach significance (Table 1 and Figure 1A). CMT decreased markedly from baseline (409.89±219.24 μm) to 3 months (277.43±113.92 μm, p<0.001), with sustained reductions at 6, 12, 18, and 24 months (all p≤0.05) (Table 1 and Figure 1B).
Table 1.
Changes in BCVA and CMT After Aflibercept Treatment
| Variables | Baseline | 3 Months | 6 Months | 12 Months | 18 Months | 24 Months | P Value |
|---|---|---|---|---|---|---|---|
| BCVA (logMAR) | 0.71±0.48 | Δ-0.13±0.35 | Δ-0.21±0.30 | Δ-0.17±0.34 | Δ-0.09±0.36 | Δ-0.15±0.27 | <0.001 |
| CMT (μm) | 409.89±219.24 | Δ-132.46±196.55 | Δ-123.78±213.73 | Δ-129.94±215.02 | Δ-109.25±267.64 | Δ-145.71±239.50 | <0.001 |
| PEDH (μm) | 235.33±128.69 | Δ-33.91±103.00 | Δ-36.25±118.67 | Δ-33.29±108.31 | Δ-2.50±226.23 | Δ-56.10±114.95 | <0.001 |
| SCT (μm) | 209.27±72.06 | Δ-18.73±85.33 | Δ-8.97±87.97 | Δ-14.25±85.46 | Δ-20.83±81.71 | Δ-34.71±89.62 | 0.046 |
| SRF (%) | 21 (56.8%) | 6 (16.2%) | 12 (33.3%) | 11 (30.6%) | 11 (30.6%) | 11 (31.4%) | 0.001 |
| IRF (%) | 18 (48.6%) | 9 (24.3%) | 9 (25.0%) | 12 (33.3%) | 11 (30.6%) | 12 (34.3%) | 0.015 |
| HRD (%) | 25 (67.6%) | 26 (70.3%) | 25 (69.4%) | 28 (77.8%) | 29 (80.6%) | 29 (82.9%) | 0.018 |
| SHE (%) | 12 (32.4%) | 11 (29.7%) | 12 (33.3%) | 11 (30.6%) | 14 (38.9%) | 14 (40.0%) | 0.047 |
| Fibrosis (%) | 6 (16.2%) | 9 (24.3%) | 9 (25.0%) | 10 (27.8%) | 10 (27.8%) | 11 (31.4%) | 0.016 |
| MA (%) | 7 (18.9%) | 9 (24.3%) | 11 (30.6%) | 12 (33.3%) | 12 (33.3%) | 14 (40.0%) | 0.001 |
| EZ disruption (%) | 21 (56.8%) | 22 (59.5%) | 22 (61.1%) | 22 (61.1%) | 22 (61.1%) | 21 (60.0%) | 0.530 |
Note: Continuous variables: Δ represents the change from baseline (mean ± SD).
Abbreviations: BCVA, Best-Corrected Visual Acuity; CMT, Central Macular Thickness; PEDH, Pigment Epithelial Detachment Height; SCT, Subfoveal Choroidal Thickness; SRF, Subretinal Fluid; IRF, Intraretinal Fluid; HRD, Hyperreflective Dots; SHE, Subretinal Hyperreflective Exudation; MA, Macular Atrophy; EZ disruption, Ellipsoid Zone disruption.
Figure 1.
Longitudinal changes in visual and anatomical parameters over 24 months. (A) Best-corrected visual acuity (BCVA, LogMAR) over time. (B) Central macular thickness (CMT, μm). (C) Pigment epithelial detachment (PED) height (μm). (D) Subfoveal choroidal thickness (SCT, μm). Data are presented as mean ± standard deviation. *p < 0.05, **p < 0.01, ***p < 0.001 versus baseline. Follow-up time points are indicated in months (m).
Compared with baseline, mean BCVA change (Δ) was −0.13±0.35 at 3 months, −0.21±0.30 at 6 months, −0.17±0.34 at 12 months, −0.09±0.36 at 18 months, and −0.15±0.27 at 24 months. CMT decreased markedly from baseline, with mean ΔCMT of −132.46±196.55 μm at 3 months, −123.78±213.73 μm at 6 months, −129.94±215.02 μm at 12 months, −109.25±267.64 μm at 18 months, and −145.71±239.50 μm at 24 months. PED height showed a significant mean reduction only at 24 months (Δ −56.10±114.95 μm, p=0.011) (Table 1 and Figure 1C), while subfoveal choroidal thickness decreased gradually, with Δ −34.71±89.62 μm at 24 months (p=0.046) (Table 1 and Figure 1D).
OCT structural features, including subretinal fluid (SRF), intraretinal fluid (IRF), and pigment epithelial detachment height (PEDH), showed marked resolution after treatment (all p<0.05). In contrast, high reflectivity dots (HRD), subretinal hyperreflective exudates (SHE), fibrosis, and macular atrophy (MA) tended to increase progressively during follow-up (all p≤0.047). EZ disruption rates remained largely stable (p=0.530) (Table 1 and Figure 2).
Figure 2.
Representative imaging biomarkers in neovascular age-related macular degeneration (nAMD). Colored arrows denote retinal lesions: pink, retinal pigment epithelium (RPE) disruption; red, subretinal hyperreflective exudation (SHE); purple, fibrosis; green, intraretinal fluid (IRF); blue, subretinal fluid (SRF). Circles indicate hyperreflective dots (HRD).
Baseline Characteristics Between Effective and Non-Effective Groups
The total number of injections was 9.19 ± 3.42, with 9.25 ± 3.34 in the effective group and 9.08 ± 3.55 in the non-effective group. Compared with the non-effective group (n=13), the effective group (n=24) had significantly higher baseline CMT (472.96±244.47 μm vs 293.46±83.72 μm, p=0.015). Baseline SRF was more frequent in the effective group (70.8% vs 30.8%, p=0.019), and HRD was also more common (79.2% vs 46.2%, p=0.041). No significant between-group differences were observed for age, sex, baseline BCVA, PED height, SCT, IRF, SHE, fibrosis, MA, or EZ disruption (all p>0.05) (Table 2).
Table 2.
Characteristics of Effective and Non-Effective Groups After Aflibercept Treatment
| Variables | Overall | Effective Group (n=24) |
Non Effective Group (n=13) |
P Value |
|---|---|---|---|---|
| Age (years, mean±SD) | 72.92±7.25 | 73.83±6.64 | 71.23±8.28 | 0.304 |
| Gender, female, n(%) | 23 (62.16%) | 14 (58.3%) | 9 (69.2%) | 0.514 |
| Number of injections | 9.19±3.42 | 9.25±3.34 | 9.08±3.55 | 0.887 |
| BCVA (logMAR) | 0.71±0.48 | 0.79±0.49 | 0.57±0.44 | 0.183 |
| CMT (μm) | 409.89±219.24 | 472.96±244.47 | 293.46±83.72 | 0.015 |
| PEDH (μm) | 235.33±128.69 | 257.57±141.12 | 196.42±96.79 | 0.194 |
| SCT (μm) | 209.27±72.06 | 215.25±85.60 | 198.23±36.44 | 0.501 |
| SRF (%) | 21 (56.8%) | 17 (70.8%) | 4 (30.8%) | 0.019 |
| IRF (%) | 18 (48.6%) | 14 (58.3%) | 4 (30.8%) | 0.109 |
| HRD (%) | 25 (67.60%) | 19 (79.2%) | 6 (46.2%) | 0.041 |
| SHE (%) | 12 (32.4%) | 8 (33.3%) | 4 (30.8%) | 0.874 |
| Fibrosis (%) | 6 (16.2%) | 3 (12.5%) | 3 (23.1%) | 0.405 |
| MA (%) | 7 (18.9%) | 4 (16.7%) | 3 (23.1%) | 0.635 |
| EZ disruption (%) | 21 (56.8%) | 14 (58.3%) | 7 (53.8%) | 0.793 |
Abbreviations: BCVA, Best-Corrected Visual Acuity; CMT, Central Macular Thickness; PEDH, Pigment Epithelial Detachment Height; SCT, Subfoveal Choroidal Thickness; SRF, Subretinal Fluid; IRF, Intraretinal Fluid; HRD, Hyperreflective Dots; SHE, Subretinal Hyperreflective Exudation; MA, Macular Atrophy; EZ disruption, Ellipsoid Zone disruption.
Predictors of Treatment Efficacy
Univariate logistic regression identified baseline CMT, SRF, and HRD as factors associated with treatment efficacy (Table 3). After adjusting for age and sex in multivariate models, higher baseline CMT (OR=1.01, 95% CI: 1.00–1.01, p=0.027) and the presence of SRF (OR=5.40, 95% CI: 1.20–24.21, p=0.028) remained independent predictors of better visual outcomes at 24 months. However, HRD showed a strong trend toward significance (OR=4.43, 95% CI: 0.97–20.34, p=0.055) (Table 4).
Table 3.
Factors Associated with Treatment Effects by Univariate Logistic Regression
| Variables | β | OR (95% CI) | P Value |
|---|---|---|---|
| BCVA (logMAR) | 1.14 | 3.12 (0.58–16.90) | 0.186 |
| CMT | 0.01 | 1.01 (1.00–1.01) | 0.027 |
| PED | 0.00 | 1.00 (1.00–1.01) | 0.192 |
| SCT | 0.00 | 1.00 (0.99–1.02) | 0.503 |
| SRF | 1.70 | 5.46 (1.26–23.77) | 0.024 |
| IRF | 1.15 | 3.15 (0.75–13.17) | 0.116 |
| HRD | 1.49 | 4.43 (1.02–19.27) | 0.047 |
| SHE | 0.12 | 1.12 (0.26–4.80) | 0.874 |
| Fibrosis | −0.74 | 0.48 (0.08–2.79) | 0.411 |
| MA | −0.41 | 0.67 (0.12–3.57) | 0.636 |
| EZ disruption | 0.18 | 1.20 (0.31–4.67) | 0.793 |
Abbreviations: BCVA, Best-Corrected Visual Acuity; CMT, Central Macular Thickness; PEDH, Pigment Epithelial Detachment Height; SCT, Subfoveal Choroidal Thickness; SRF, Subretinal Fluid; IRF, Intraretinal Fluid; HRD, Hyperreflective Dots; SHE, Subretinal Hyperreflective Exudation; MA, Macular Atrophy; EZ disruption, Ellipsoid Zone disruption; SE, Standard Error; OR, Odds Ratio; CI, Confidence Interval.
Table 4.
Factors Associated with Treatment Effects by Multi Variable Logistic Regression
| Variables | SE | OR (95% CI) | P value |
|---|---|---|---|
| CMT | 0.003 | 1.01 (1.00–1.01) | 0.030 |
| SRF | 4.13 | 5.40 (1.20–24.21) | 0.028 |
| HRD | 3.45 | 4.43 (0.97–20.34) | 0.055 |
Note: Adjusted with age, and sex.
Abbreviations: CMT, Central Macular Thickness; SRF, Subretinal Fluid; IRF, Intraretinal Fluid; HRD, Hyperreflective Dots; SE, Standard Error; OR, Odds Ratio; CI, Confidence Interval.
Discussion
In this real-world study, we evaluated the long-term efficacy of intravitreal aflibercept using a T&E regimen for nAMD in a Chinese population. Over a 24-month follow-up, we observed significant improvements in BCVA and sustained reductions in CMT, with consistent resolution of exudative changes on OCT. These findings support the effectiveness of the T&E strategy in real-world settings, providing a balance between clinical outcomes and treatment burden.
In this study, the primary endpoint of effectiveness was defined as an ETDRS visual acuity improvement of ≥ 5 letters at the 24th month. This is roughly equivalent to a clinical significance of ≥ 0.1 improvement in LogMAR visual acuity, which is in line with the common practice in international ophthalmology clinical research.13
The visual gains in our study (ΔBCVA of −0.13 to −0.21 logMAR within the first year and maintained at 24 months) are comparable to those reported in pivotal randomized controlled trials such as VIEW 1 and VIEW 2, as well as real-world cohorts adopting T&E regimens.14–16 Notably, although visual improvements plateaued after 12 months, CMT reduction remained significant throughout the study period, suggesting that anatomical stabilization may precede or exceed functional recovery in certain patients. Similar dissociation between functional and anatomical outcomes has been highlighted in prior reports, underscoring the need for multimodal assessment of treatment response. In addition, Tsunekawa et al reported the 4-year outcomes of aflibercept under a TAE regimen in Japanese patients with nAMD, noting that only 6.7% of treated eyes experienced a loss of more than 0.3 logMAR in visual acuity.17 By contrast, another study found that 10 of 42 eyes (23.8%) showed a decline of ≥0.3 logMAR after 5 years of follow-up.18 In our study, 25 of 37 eyes (67.6%) achieved visual acuity improvement during a 2-year observation period in China. This discrepancy may be explained by several factors, including differences in baseline characteristics, variations in patient adherence and follow-up completion, ethnicity-related genetic and lifestyle differences, and disparities in clinical practice patterns across regions. Moreover, the shorter observation period in our study may have reduced the likelihood of capturing late visual decline, which often becomes more evident with longer-term follow-up.
Our OCT analyses further demonstrated dynamic structural changes during therapy. Exudative features, including SRF, IRF, and PEDH, were effectively resolved, while degenerative features such as fibrosis, MA, and HRD increased progressively during follow-up.19 This pattern reflects the dual therapeutic course of nAMD, in which suppression of neovascular leakage can mitigate acute exudation, whereas chronic remodeling and atrophy may continue to progress despite anti-VEGF therapy.20 The stability of EZ disruption observed in our cohort suggests that photoreceptor integrity may be relatively preserved under sustained aflibercept treatment, although longer follow-up is warranted.21
The observation that BCVA improvement did not achieve statistical significance at 18 months, despite overall sustained efficacy, can be attributed to several interacting factors within the context of nAMD treated with a T&E protocol. Firstly, the dynamic nature of the T&E protocol may lead to transient fluctuations in disease activity or minor relapses at certain time points. Such temporary oscillations in macular edema or fluid status could, in turn, affect BCVA measurements, resulting in a temporary reduction in the magnitude of improvement or an increase in data variability. Real-world studies of anti-VEGF therapies often demonstrate similar visual acuity fluctuations over long-term follow-up, rather than a strictly linear improvement, even under effective disease control.22 Secondly, the progression of degenerative ocular features significantly impacts long-term visual outcomes. Our study identified a gradual increase in HRD, SHE and MA throughout the follow-up period. These degenerative changes represent irreversible structural damage that can profoundly limit the potential for visual recovery, even when VEGF is effectively suppressed. At 18 months, some patients may have accumulated sufficient degenerative pathology to cap further BCVA gains, leading to a plateau or even a slight decline in visual function. Also, the absence of statistical significance at a single time point (18 months) does not negate the presence of clinically meaningful improvement. The mean BCVA improvement at 18 months was −0.09 ± 0.36 logMAR, which still represents a clinical gain. Statistical significance is influenced by factors such as effect size, sample size, and data variability. While the predetermined p-value threshold may not have been met at 18 months, consistent and statistically significant BCVA improvements were observed at other key time points (eg, 3, 6, 12, and 24 months). This suggests that the 18-month data point might reflect transient “noise” resulting from the complex interplay of treatment dynamics and progressive degenerative changes, rather than a fundamental loss of overall treatment efficacy.
An important aspect of our study was the identification of baseline imaging biomarkers associated with treatment response.21,23 Higher baseline CMT and the presence of SRF were predictive of favorable visual outcomes at 24 months, consistent with previous reports suggesting that patients with more pronounced exudative activity may derive greater benefit from anti-VEGF therapy.24,25 HRD also showed a strong trend toward predicting efficacy but without significance, in line with studies linking HRD to inflammatory or lipid exudates that may be responsive to VEGF suppression. These are consistent with prior observations, supporting the trend that HRD may serve as a predictive biomarker for anti-VEGF efficacy.26,27 And all these findings in our study highlight the utility of OCT-derived biomarkers in guiding individualized treatment strategies and prognostication in nAMD.
Several limitations should be acknowledged. First, this was a retrospective, single-arm study, and the absence of a control group limits causal inference. Second, the sample size was modest, which may reduce the statistical power for subgroup analyses. Third, although the 24-month follow-up provides valuable long-term data, further longitudinal studies are needed to assess durability beyond two years. Finally, potential confounders such as treatment adherence, systemic factors, and genetic predisposition were not fully accounted for, thus further comprehensive study with more information should be conducted.
Conclusion
In conclusion, our findings demonstrate that aflibercept administered under a T&E protocol achieves sustained visual and anatomical improvements in Chinese patients with nAMD. Baseline OCT features, particularly higher CMT and the presence of SRF, may serve as useful predictors of treatment response. These results support the clinical utility of individualized T&E regimens and underscore the importance of OCT biomarkers in optimizing outcomes for patients with nAMD.
Data Sharing Statement
The datasets used and/or analyzed during the current study are available from the corresponding author on reasonable request.
Ethics Approval and Consent to Participate
This study was approved by the Ethics Committee of the Third People’s Hospital of Dalian (approval number: 2021-060-001) and was conducted in accordance with the principles of the Declaration of Helsinki. Written informed consent was obtained from all participants prior to study enrollment.
Disclosure
The authors declare no conflicts of interest in this work.
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Associated Data
This section collects any data citations, data availability statements, or supplementary materials included in this article.
Data Availability Statement
The datasets used and/or analyzed during the current study are available from the corresponding author on reasonable request.