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).
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
107
Pre-filled syringe for intravitreal injection
PRP treatment following DRS guidelines
Novartis Investigative Site
Aachen, Germany
Novartis Investigative Site
Augsburg, Germany
Change From Baseline in Area of Neovascularizations (NVs) at End of Core Study (EOCS)
The area of neovascularizations (NV) was assessed by a central reading center via fluorescein angiography (FA) images. The area of NV was calculated as the sum of area of neovascularization of the disc (NVD) and neovascularization elsewhere (NVE) and was recorded in square millimeters. A higher positive change value may indicate a greater formation of new, abnormal blood vessels and thus disease progression. One eye (study eye) contributed to the analysis.
Time frame: Baseline, EOCS
Change From Baseline in Area of Neovascularizations (NVs) at Month 3
The area of neovascularizations (NV) was assessed by a central reading center via fluorescein angiography (FA) images. The area of NV was calculated as the sum of area of neovascularization of the disc (NVD) and neovascularization elsewhere (NVE) and was recorded in square millimeters. A higher positive change value may indicate a greater formation of new, abnormal blood vessels and thus disease progression. One eye (study eye) contributed to the analysis.
Time frame: Baseline, Month 3
Best Corrected Visual Acuity (BCVA) (ETDRS Letters) at EOCS
BCVA was assessed using Early Treatment Diabetic Retinopathy Study (ETDRS)-like charts at a testing distance of 4 meters. A higher number of ETDRS letters may indicate better visual acuity. One eye (study eye) contributed to the analysis.
Time frame: EOCS
Percentage of Patients With Change From Baseline in BCVA (ETDRS Letters) at EOCS
BCVA was assessed using Early Treatment Diabetic Retinopathy Study (ETDRS)-like charts at a testing distance of 4 meters. No clinically relevant change was defined as \<5 letters gain or loss. A higher positive change value may indicate a greater improvement in visual acuity. One eye (study eye) contributed to the analysis.
Time frame: Baseline, EOCS
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Novartis Investigative Site
Berlin, Germany
Novartis Investigative Site
Cologne, Germany
Novartis Investigative Site
Darmstadt, Germany
Novartis Investigative Site
Düsseldorf, Germany
Novartis Investigative Site
Essen, Germany
Novartis Investigative Site
Freiburg im Breisgau, Germany
Novartis Investigative Site
Glauchau, Germany
Novartis Investigative Site
Göttingen, Germany
...and 13 more locations
Number of Patients With Change From Baseline in ETDRS Severity Grade of Diabetic Retinopathy (DR) at EOCS
The severity level of diabetic retinopathy was determined using the ETDRS severity scale. However, in contrast to the original ETDRS severity scale, wide field fluorescein angiography images were used in addition to color fundus photography for identification of NVs and prior PRP treatment was not considered for determining the severity level. Eyes could be graded in the following classes: "DR absent" (10), "questionable DR" (14,15), "NPDR" (20-53), "mild PDR" (60-61), "moderate PDR" (65), "high risk PDR" (71-75), "advanced PDR" (81-85) and "cannot grade" (90). One eye (study eye) contributed to the analysis. No statistical analysis was conducted for ≥ 1 class deterioration or ≥ 2 class deterioration from Baseline at EOCS because ratios could not be calculated in case of zero frequencies in at least one of the three treatment groups.
Time frame: Baseline, EOCS
Change From Baseline in Central Subfield Thickness at EOCS
Central subfield retinal thickness was assessed by a central reading center using Optical Coherence Tomography images. A positive change value may indicate disease progression. One eye (study eye) contributed to the analysis.
Time frame: Baseline, EOCS
Change From Baseline in Foveal Center Point Retinal Thickness at EOCS
Foveal center point retinal thickness was assessed by a central reading center using Optical Coherence Tomography images. A positive change value may indicate disease progression. One eye (study eye) contributed to the analysis.
Time frame: Baseline, EOCS
Number of Ranibizumab Injections Until EOCS
The total number of ranibizumab injections until EOCS was calculated. One eye (study eye) contributed to the analysis. No statistical analysis was conducted.
Time frame: Baseline to EOCS
Number of PRP Laser Spots Until EOCS
The total number of PRP laser spots from baseline until EOCS was calculated. One eye (study eye) contributed to the analysis. No statistical analysis was conducted.
Time frame: Baseline to EOCS