PASCAL Laser Versus ETDRS Laser Associated With Intravitreal Ranibizumab (IVR) Versus Only IVR for Proliferative Diabetic Retinopathy

Conditions

• Proliferative Diabetic Retinopathy

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Intravitreal Ranibizumabe — DRUG
  Intravitreal injection 0,05ml Ranibizumabe
• panfotocoagulation (PASCAL) — DRUG
• panfotocoagulation (PRP) single shoot (ETDRS) — DRUG

Study Details

Objectives: Primary objective: To evaluate the effects on retinal morphophysiology of full scatter single target panretinal photocoagulation (PRP) versus full scatter multiple target panretinal photocoagulation (both combined with intravitreous injections of ranibizumab) versus intravitreous ranibizumab (IVR) alone in patients with proliferative diabetic retinopathy (PDR). Primary outcome: The primary endpoint for this study is the mean change in the total area of active retinal neovessels, as measured by fluorescein angiography leakage area, in mm2, from baseline to week 48. Secondary objectives: * To assess the mean changes in best corrected visual acuity (BCVA), the mean changes in central subfield foveal thickness (CSFT), the mean changes in wave B amplitude and oscillatory potentials on a full-field electroretinogram (ERG), and the mean changes on the peripheral visual field by static perimetry (30:2 strategy), from baseline to week 48. * To assess the incidence of adverse events during the study. Strategic goal: In the era of anti-VEGF treatment for retinal neovascularization 1, 2, 3, 4 , it is time to determine what would be the best association of PRP + anti-VEGF for proliferative diabetic retinopathy (PDR), or still, if just intravitreal anti-VEGF treatment would be even better regarding morphologic (new vessels area and CSFT) and functional parameters (BCVA, ERG response and visual field).

Key Dates

First listed

Dec 9, 2013

Start date

Feb 29, 2012

Status verified

Dec 2013

Primary completion

Nov 30, 2014

Study Design

Enrollment

31 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Active Comparator: SS-PRP arm
  panfotocoagulation (PRP) single shoot (ETDRS) + 0,05ml intravitreal injection anti-VEGF (ranibizumabe)
• Experimental: MS-PRP arm
  Multiple shoot panfotocoagulation (PASCAL) plus IVR
• Other: IVR arm
  only IVR (intravitreal Ranibizumabe)

Primary Outcome Measure

fluorescein angiography leakage area [ Time Frame: from baseline to week 48. ]