Phase 2
Completed N=108
Multicenter 12 Months Clinical Study to Evaluate Efficacy and Safety of Ranibizumab Alone or in Combination With Laser Photocoagulation vs. Laser Photocoagulation Alone in Proliferative Diabetic Retinopathy (PRIDE)
Proliferative Diabetic Retinopathy (PDR)
Source: ClinicalTrials.gov NCT01594281 ↗
Enrolled (actual)
108
Serious AEs
31.3%
Results posted
Mar 2019
Primary outcomePrimary: Change From Baseline in Area of Neovascularizations (NVs) at End of Core Study (EOCS) — -4.6; -0.9; -1.7 square millimeters — p=0.0344
Summary
The purpose of this study was to assess the efficacy and safety of the anti-Vascular Endothelial Growth Factor (VEGF) agent ranibizumab (0.5 mg) with or without Panretinal laser photocoagulation (PRP) compared to PRP alone in patients with Proliferative Diabetic Retinopathy (PDR).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Area of Neovascularizations (NVs) at End of Core Study (EOCS) |
-4.6; -0.9; -1.7 | 0.0344 sig |
| SECONDARY Change From Baseline in Area of Neovascularizations (NVs) at Month 3 |
-5.9; -0.7; -2.7 | 0.0081 sig |
| SECONDARY Best Corrected Visual Acuity (BCVA) (ETDRS Letters) at EOCS |
84.4; 76.8; 78.9 | 0.0495 sig |
| SECONDARY Percentage of Patients With Change From Baseline in BCVA (ETDRS Letters) at EOCS |
0.0; 2.9; 0.0; 5.7; 11.4; 8.3 | 0.4019 |
| SECONDARY Number of Patients With Change From Baseline in ETDRS Severity Grade of Diabetic Retinopathy (DR) at EOCS |
10; 9; 13; 2; 2; 5 | 0.9918 |
| SECONDARY Change From Baseline in Central Subfield Thickness at EOCS |
-6.0; 36.2; 17.6 | 0.0003 sig |
| SECONDARY Change From Baseline in Foveal Center Point Retinal Thickness at EOCS |
-4.7; 48.1; 25.5 | 0.0007 sig |
| SECONDARY Number of Ranibizumab Injections Until EOCS |
5.2; NA; 5.0 | — |
| SECONDARY Number of PRP Laser Spots Until EOCS |
NA; 1919.4; 1670.0 | — |
Eligibility Criteria
Inclusion Criteria
- Proliferative Diabetic Retinopathy
- Best Corrected Visual Acuity (BCVA) in study eye of at least 20 Early Treatment Diabetic Retinopathy Study (ETDRS) letters (20/400)
- Type 1 or type 2 diabetes under medical surveillance / with stabilized treatment
Exclusion Criteria
- Proliferative vitreoretinopathy in study eye
- Clinically significant macular edema (CSME) in the study eye
- Clinically non significant macular edema (CNSME) that is likely to develop to CSME in the study eye
- Uncontrolled glaucoma in either eye
- Other protocol-specified conditions
Data sourced from ClinicalTrials.gov (NCT01594281). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.