Table 3.
Interventional trials in diabetic retinopathy
| Clinical trials | Clinical trials’ number | Year | Phase | Participants (n) | Intervention | Follow-up | Main outcome | Adverse events |
|---|---|---|---|---|---|---|---|---|
| Sodium-glucose cotransporter-2 (SGLT2) inhibitors | ||||||||
| Dapagliflozin511 | NCT02919345 (Completed) | 2017 | / | 97 |
I: Dapagliflozin C: glibenclamide |
12 weeks | Central retinal thickness | Not reported |
| Dapagliflozin plus another oral hypoglycemic agent | NCT05310916 (Ongoing) | 2022 | 3 | 60 |
I:Dapagliflozin 10 mg Tab plus another oral hypoglycemic agent C:Two oral hypoglycemic agents other than dapagliflozin |
12 weeks | Severity of retinopathy | / |
| Others | ||||||||
| Faricimab512 | NCT03622580 (Completed) | 2018 | 3 | 1891 |
I:faricimab C:faricimab per personalized treatment interval or aflibercept |
1 year | Mean change in best-corrected visual acuity | Intraocular inflammation |
| Brolucizumab513 | NCT03321513 (Completed) | 2017 | 3a | 270 (312 eyes) |
I:Brolucizumab C: aflibercept |
2 years | Mean best-corrected visual acuity; Retinal central subfield thickness and visual acuity | Retinal vasculitis and retinal vascular occlusion |
| Abicipar514 |
NCT02462486 (Completed) |
2015 | 3 | 1888 |
I: Abicipar C: ranibizumab |
52 weeks | Stable vision, best-corrected visual acuity, central retinal thickness | Intraocular inflammation |
| Fenofibrate515 | NCT01927315 (Completed) | 2013 | 4 | 41 |
I: Fenofibrate C: placebo |
12 weeks | Change in the levels of circulating hematopoietic stem/progenitor cells | Ischaemic stroke related to pre-existing conditions |
| PDS implant pre-filled with ranibizumab | NCT04503551 (Ongoing) | 2020 | 3 | 174 |
I: PDS implant pre-filled with ranibizumab C: Intravitreal ranibizumab |
52 weeks | Early treatment diabetic retinopathy study, diabetic retinopathy severity scale | / |
| OPL-0401 | NCT05393284 (Ongoing) | 2022 | 2 | 120 |
I: OPL-0401 C: Placebo |
24 weeks | Improvement in diabetic retinopathy severity scale | / |
| Calcium Dobesilate | NCT04283162 (Ongoing) | 2020 | 4 | 1200 |
I:Calcium dobesilate + conventional treatment C:conventional treatment |
12 months | The rate of the progression of diabetic retinopathy | / |
| Sinemet CR | NCT05132660 (Ongoing) | 2022 | 1 | 244 |
I:Sinemet CR C:placebo |
24 months | Electroretinogram | / |
| Aflibercept | NCT04708145 (Ongoing) | 2021 | 4 | 150 | Eyes without panretinal photocoagulation (PRP) and eyes with PRP, Drug: Aflibercept Injection | 112 weeks | Improvement in diabetic retinopathy severity scale | / |