Prospective, Randomized, Open Label, Phase II Study to Assess Efficacy and Safety of Macugen® (Pegaptanib 0.3 mg Intravitreal Injections) Plus Panretinal Photocoagulation (PRP) and PRP (Monotherapy) in the Treatment of Patients With High Risk Proliferative Diabetic Retinopathy (PDR).

NCT01281098 Phase 2 COMPLETED

To evaluate the safety and determine the efficacy of PRP monotherapy or combination therapy (pegaptanib 0.3 mg plus PRP) in patients with Type I or Type II diabetes mellitus and with high risk proliferative diabetic retinopathy.

Details

Lead sponsor	Association for Innovation and Biomedical Research on Light and Image
Phase	Phase 2
Status	COMPLETED
Enrolment	22
Start date	2010-03
Completion	2013-02

Conditions

• High Risk Proliferative Diabetic Retinopathy
• Diabetes Mellitus Type I
• Diabetes Mellitus Type II

Interventions

• Panretinal Photocoagulation (PRP)
• Intravitreous injection of pegaptanib

Primary outcomes

• Regression of retinal neovascularization — 12-month treatment
  Retinal neovascularization will be measured in disc area units, and progression of neovascularization will be defined as an increasing of 0.5 disc area associated or not with vitreous haemorrhage, and/or pre-retinal haemorrhage, and/or rubeosis, and/or traccional retinal detachment.

Countries

Portugal