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)

Sponsor
Novartis Pharmaceuticals
Study ID
NCT01594281
Phase
PHASE2
Status
Completed

Conditions

  • Proliferative Diabetic Retinopathy (PDR)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Ranibizumab 0.5 mg — DRUG
    Pre-filled syringe for intravitreal injection
  • Panretinal laser photocoagulation — PROCEDURE
    PRP treatment following DRS guidelines

Study Details

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).

Key Dates

First listed
May 9, 2012
Start date
Dec 11, 2012
Status verified
Nov 2018
Primary completion
Nov 30, 2016
Completion
Dec 5, 2017

Study Design

Enrollment
107 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Ranibizumab mono
    Interventional Core Phase: One intravitreal injection of ranibizumab 0.5 mg to the study eye monthly until stability regarding morphological parameters is confirmed (ie, no further improvement of morphology or no worsening of morphology for 3 consecutive months)
  • Active Comparator: PRP mono
    Interventional Core Phase: Panretinal laser photocoagulation (PRP) treatment administered to the study eye in accordance with the modified diabetic retinopathy study (DRS) guidelines for panretinal laser photocoagulation procedures
  • Experimental: Ranibizumab+PRP
    Interventional Core Phase: Ranibizumab 0.5 mg as described for the ranibizumab mono arm and PRP treatment as described for the PRP mono arm until stability regarding morphological parameters is confirmed

Primary Outcome Measure

Change From Baseline in Area of Neovascularizations (NVs) at End of Core Study (EOCS) [ Time Frame: Baseline, EOCS ]

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