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

Diabetes Mellitus Type II Clinical Trial

Official title:
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).

Status Completed

Clinical Trial Summary

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.

Clinical Trial Description

Panretinal photocoagulation (PRP) can cause regression of retinal neovascularization and reduce the risk of severe vision loss in people with proliferative diabetic retinopathy (PDR). However, this destructive treatment may be associated with side effects (e.g. pain, transient blurring, loss of peripheral and/or night vision, increased risk of macular edema and central vision loss) and it is not always efficient in the regression of the neovascularization.

Vascular endothelial growth factor (VEGF) has been shown to play a role in retinal neovascularization and retinal vascular leakage related with PDR and diabetic macular edema.

Anti-VEGF treatments have been hypothesized as an adjunctive treatment for the management of retinal neovascularization and macular edema related with diabetic retinopathy (DR).

Anti-VEGF agents, such as Macugen®, combined with PRP are expected to control neovascularization without the need for photocoagulation of the posterior pole, around the macula, thus avoiding the major side effects of standard PRP (visual field loss).

A modification of panretinal photocoagulation (PRP) was recently proposed by Madeira et al., (2009) at the 2009 EURETINA Meeting. The described technique involves the progressive application of the DRS photocoagulation rings in a different sequence. First ring: corresponds to the DRS third ring, extruding from the ora serrata to the midperiphery. Second ring: corresponds to DRS second ring, extruding from the midperiphery towards the vortex veins. Third ring: corresponds to DRS first ring, and will only be performed if necessary. This technique resulted in less aggressive visual fields losses by achieving results with only most peripheral photocoagulation. The combination of intravitreal anti-VEGF treatment with pegaptanib, where a series of 3 injections are injected to reverse the neovascularization, while maintaining the macula dry will be completed by the more long term effect of the panretinal photocoagulation. This peripheral photocoagulation proposed is expected to eliminate the chronic VEGF stimulus by eliminating the chronic ischemic factor, while maintaining the visual fields useful for daily activities such as driving, etc. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Diabetes Mellitus
Diabetes Mellitus Type I
Diabetes Mellitus Type II
Diabetes Mellitus, Type 1
Diabetes Mellitus, Type 2
Diabetic Retinopathy
High Risk Proliferative Diabetic Retinopathy
Retinal Diseases

Clinical Trial Details

NCT number	NCT01281098
Study type	Interventional
Source	Association for Innovation and Biomedical Research on Light and Image
Contact
Status	Completed
Phase	Phase 2
Start date	March 2010
Completion date	February 2013

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.