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)

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

107 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-12-11

Study Completion Date

2017-12-05

Brief Summary

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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).

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Detailed Description

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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.

Conditions

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Proliferative Diabetic Retinopathy (PDR)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

An open-label design was chosen in which the evaluation of the primary objective was performed by a reading center. The reading center that evaluated the primary and several secondary objectives was blinded to randomization and therefore assessed these objectives uninfluenced by treatment information. However, laser burns were visible on the images, and no full blinding regarding panretinal laser photocoagulation (PRP) was possible for the reading center.

Study Groups

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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)

Group Type EXPERIMENTAL

Ranibizumab 0.5 mg

Intervention Type DRUG

Pre-filled syringe for intravitreal injection

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

Group Type ACTIVE_COMPARATOR

Panretinal laser photocoagulation

Intervention Type PROCEDURE

PRP treatment following DRS guidelines

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

Group Type EXPERIMENTAL

Ranibizumab 0.5 mg

Intervention Type DRUG

Pre-filled syringe for intravitreal injection

Panretinal laser photocoagulation

Intervention Type PROCEDURE

PRP treatment following DRS guidelines

Interventions

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Ranibizumab 0.5 mg

Pre-filled syringe for intravitreal injection

Intervention Type DRUG

Panretinal laser photocoagulation

PRP treatment following DRS guidelines

Intervention Type PROCEDURE

Other Intervention Names

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Lucentis® RFB002 PRP

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No