This trial is active, not recruiting.

Condition proliferative diabetic retinopathy (pdr)
Treatments ranibizumab, laser photocoagulation, ranibizumab & laser photocoagulation
Phase phase 4
Target VEGF
Sponsor Novartis Pharmaceuticals
Collaborator Cologne Image Reading Center & Laboratory (CIRCL)
Start date December 2012
End date January 2018
Trial size 107 participants
Trial identifier NCT01594281, 2011-005542-35, CRFB002DDE21


This study will assess the efficacy and safety of Ranibizumab alone or in combination with laser treatment vs. laser treatment alone in Proliferative Diabetic Retinopathy. Efficacy will be primarily measured by the change of area of neovascularizations as measured by Fluorescein Angiography at month 12 (difference to baseline value).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose treatment
(Active Comparator)
laser photocoagulation
ranibizumab & laser photocoagulation

Primary Outcomes

Change of area of neovascularizations as measured by Fluorescein
time frame: baseline and month 12

Secondary Outcomes

BCVA in all patients (ETDRS letters)
time frame: baseline and month 12
Change in classification of DR based on the ETDRS severity scale (assessed by FP)
time frame: baseline, month 3 and month 12
Change in retinal thickness (OCT)
time frame: baseline, month 3 and month 12
Rates of patients (%)
time frame: baseline, month 3 and month 12

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Proliferative Diabetic Retinopathy - BCVA ≥ 20 ETDRS letters - Diabetes mellitus with HbA1c ≤ 12% (=107 mmol/mol) Exclusion Criteria: - Proliferative vitreoretinopathy - Clinically significant macular edema (CSME) - Clinically non significant macular edema likely to develop to CSME - NVD ≥ 2 DA or multiple NVE with a combined area of ≥ 2 DA involving the macula - Vitreous hemorrhage - Vitreomacular traction - Previous scattered PRP treatment

Additional Information

Official title Multicenter Randomized Open-label Three-arms Controlled 12 Months Clinical Proof of Concept Study to Evaluate Efficacy and Safety of Ranibizumab Alone or in Combination With Laser Photocoagulation vs. Laser Photocoagulation Alone in Proliferative Diabetic Retinopathy
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by Novartis.