Clinical trial NCT01594281: 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)
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Proliferative Diabetic Retinopathy (PDR)
Keywords: Panretinal photocoagulation
Ranibizumab
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2012-05-09
Enrollment: 107
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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).

Detailed 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.

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

Primary outcomes:
measure: Change From Baseline in Area of Neovascularizations (NVs) at End of Core Study (EOCS)
timeFrame: Baseline, EOCS
Secondary outcomes:
measure: Change From Baseline in Area of Neovascularizations (NVs) at Month 3
timeFrame: Baseline, Month 3
measure: Best Corrected Visual Acuity (BCVA) (ETDRS Letters) at EOCS
timeFrame: EOCS
measure: Percentage of Patients With Change From Baseline in BCVA (ETDRS Letters) at EOCS
timeFrame: Baseline, EOCS
measure: Number of Patients With Change From Baseline in ETDRS Severity Grade of Diabetic Retinopathy (DR) at EOCS
timeFrame: Baseline, EOCS
measure: Change From Baseline in Central Subfield Thickness at EOCS
timeFrame: Baseline, EOCS
measure: Change From Baseline in Foveal Center Point Retinal Thickness at EOCS
timeFrame: Baseline, EOCS
measure: Number of Ranibizumab Injections Until EOCS
timeFrame: Baseline to EOCS
measure: Number of PRP Laser Spots Until EOCS
timeFrame: Baseline to EOCS
Other outcomes:
Locations:
city: Aachen
country: Germany
facility: Novartis Investigative Site
city: Augsburg
country: Germany
facility: Novartis Investigative Site
city: Berlin
country: Germany
facility: Novartis Investigative Site
city: Darmstadt
country: Germany
facility: Novartis Investigative Site
city: Duesseldorf
country: Germany
facility: Novartis Investigative Site
city: Essen
country: Germany
facility: Novartis Investigative Site
city: Freiburg
country: Germany
facility: Novartis Investigative Site
city: Glauchau
country: Germany
facility: Novartis Investigative Site
city: Gottingen
country: Germany
facility: Novartis Investigative Site
city: Hamburg
country: Germany
facility: Novartis Investigative Site
city: Hösbach
country: Germany
facility: Novartis Investigative Site
city: Karlsruhe
country: Germany
facility: Novartis Investigative Site
city: Koeln
country: Germany
facility: Novartis Investigative Site
city: Leipzig
country: Germany
facility: Novartis Investigative Site
city: Mainz
country: Germany
facility: Novartis Investigative Site
city: Marburg
country: Germany
facility: Novartis Investigative Site
city: Muenchen
country: Germany
facility: Novartis Investigative Site
city: Muenster
country: Germany
facility: Novartis Investigative Site
city: Muenster
country: Germany
facility: Novartis Investigative Site
city: München
country: Germany
facility: Novartis Investigative Site
city: Regensburg
country: Germany
facility: Novartis Investigative Site
city: Tübingen
country: Germany
facility: Novartis Investigative Site
city: Ulm
country: Germany
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: