TABLE 1.
As per a search on clinicaltrials.gov on 7/1/2023, 35 clinical studies have been done using aptamers. The studies concluded with available data have been included in the table above. Numerous studies are recruiting participants or have been completed and are awaiting published data. These studies carry a wide breadth, including applications in COVID-19 diagnostics, measuring HIV-PrEP compliance, cancer detection, anticoagulation systems, and stem cell transplantation.
Study Title | Patient Population | Intervention | Metric | Outcome | Source |
---|---|---|---|---|---|
A Study to Establish the Safety and Tolerability of Zimura® (Anti-C5 Aptamer) in Combination with Anti-VEGF Therapy in Subjects with Idiopathic Polypoidal Choroidal Vasculopathy (IPCV) (Phase 2) |
4 subjects with idiopathic polypoidal choroidal vasculopathy who had prior treatment with anti-VEGF monotherapy | Patients were given monthly intravitreous injections of the anti-C5 aptamer in combination with anti-VEGF therapy | -Number of participants with > 15 Early Treatment of Diabetic Retinopathy Study (ETDRS) letter loss at 3 months -Number of participants with ophthalmic adverse events -Number of participants with systemic adverse events |
-0/4 had >15 ETDRS letter loss at 3 months -Average of 2.75 micrometer decrease in retinal thickness -No change in polyps at month 3 -3/4 subjects had conjunctival hemorrhage -1/4 subjects had endophthalmitis |
NCT02397954 |
A Safety and Efficacy Study of E10030 (Anti-PDGF Pegylated Aptamer) Plus Lucentis for Neovascular Age-Related Macular Degeneration (Phase 2) |
449 patients with subfoveal choroidal neovascularization due to age-related macular degeneration (AMD) | -Lucentis alone -E10030 low dose plus Lucentis -E10030 high dose plus Lucentis |
-Change in visual acuity from baseline at 24 weeks -Proportion of subjects that gained 15 ETDRS letters from baseline at week 24 -Proportion of patients with at least 1 adverse event |
-Visual acuity in ETDRS letters (Lucentis 6.5; Low dose 8.8; high dose 10.6) -ETDRS letters gained (Lucentis 34; low dose 33.3; high dose 39.1) Adverse events (Lucentis 65.5%; Low dose 67.1%; high dose 65.1) |
NCT01089517 |
A 24 Month Phase 2A Open Label, Randomized Study of Avastin®, Lucentis®, or Eylea® (Anti-VEGF Therapy) Administered in Combination with Fovista® (Anti-PDGF BB Pegylated Aptamer) (Phase 2) |
60 subjects that have active subfoveal choroidal neovascularization due to age-related macular degeneration | - Fovista® plus bevacizumab intravitreal injection - Fovista® plus ranibizumab intravitreal injection - Fovista® plus aflibercept intravitreal injection |
-Total number of systemic adverse events in 2 years -Total number of other adverse Events |
-This study was terminated before its completion -Adverse events before termination (Fovista® plus bevacizumab 71.4%; Fovista® plus ranibizumab 76.2%; Fovista® plus aflibercept 76.2) |
NCT02387957 |
Phase 2A Open Label Safety Study of Fovista® (Anti-PDGF BB) Regimen Administered in Combination with Anti-VEGF Therapy to Study Sub-Retinal Fibrosis in Neovascular AMD (Phase 2) |
101 subjects with all fluorescin angiographic subtypes with presence of active choroidal neovascularization in age-related macular degeneration | - Fovista® (anti-PDGF BB) plus anti-VEGF as a "Pre-Treatment" regimen - Fovista® (anti-PDGF BB) plus anti-VEGF as a "Simultaneous" regimen |
-Total number of systemic adverse events in 2 years -Total number of other adverse Events |
-Non-serious adverse events (Pretreatment 89.5%; Simultaneous 81%) -Serious adverse events (Pretreatment 21.1%; Simultaneous 30.2%) |
NCT02214628 |
A Phase 2/3 Randomized, Double-Masked, Controlled Trial to Assess the Safety and Efficacy of Intravitreous Administration of Zimura™ (Anti-C5 Aptamer) in Subjects with Geographic Atrophy Secondary to Dry Age-Related Macular Degeneration (Phase 2 & 3) |
286 Subjects with non-foveal geographical atrophy secondary to dry age-related macular degeneration | -Part 1 (Low Dose, high dose, sham) -Part 2 (High dose + sham, high dose + high dose, sham + sham) -During all parts patients were injected monthly for 18 months |
-Change in geographical atrophy (GA) from baseline to months 12 -Change in best corrected visual acuity |
-Change in atrophy combined part 1 & 2 (Low dose .292, High dose .321, sham - .402) -Change in visual acuity combined part 1 & 2 (Low dose -7.90, High dose -3.79, Sham -9.29) |
NCT02686658 |
A Phase 3 Safety and Efficacy Study of Fovista® (E10030) Intravitreous Administration in Combination with Lucentis® Compared to Lucentis® Monotherapy (Phase 3) **There are 2 similar Stage 3 studies on E10030 that were terminated (NCT01940900 and NCT01940887) |
622 subjects with active subfoveal choroidal neovascularization secondary to age-related macular degeneration | -E10030 plus ranibizumab -Sham plus ranibizumab |
-Change in visual acuity from baseline to 12 months -Adverse Effects |
-This study was terminated before everyone completed the treatment course (The serious adverse events were 15.48% in treatment group compared to 11.65% in the control. The nonserious event rate was 39.68% in treatment vs 36.89% in control) -There was no statistically significant difference in visual acuity between the groups |
NCT01944839 |
As per a search on clinicaltrials.gov on 7/1/2023, 35 clinical studies have been done using aptamers. The studies concluded with available data have been included in the table above. Numerous studies are recruiting participants or have been completed and awaiting published data. These studies carry a wide breadth, including applications in COVID-19 diagnostics, measuring HIV-PrEP compliance, cancer detection, anticoagulation systems, and stem cell transplantation.