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)

Novartis

Status and phase: Completed; Phase 2

Conditions: Proliferative Diabetic Retinopathy (PDR)

Treatments: Procedure: Panretinal laser photocoagulation; Drug: Ranibizumab 0.5 mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT01594281

2011-005542-35 (EudraCT Number)

CRFB002DDE21

Details and patient eligibility

About

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).

Full description

A 12-month core phase was followed by a 12-month observational follow-up phase (physician's routine), for a planned individual study duration of 24-25 months. A separate informed consent was signed for the 12-month observational follow-up phase. This study was conducted in Germany.

Enrollment: 107 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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107 participants in 3 patient groups

Ranibizumab mono

Experimental group

Description:

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)

Treatment:

Drug: Ranibizumab 0.5 mg

PRP mono

Active Comparator group

Description:

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

Treatment:

Procedure: Panretinal laser photocoagulation

Ranibizumab+PRP

Experimental group

Description:

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

Treatment:

Drug: Ranibizumab 0.5 mg

Procedure: Panretinal laser photocoagulation