High Risk Proliferative Diabetic Retinopathy Clinical Trial
Official title:
Prospective, Randomized, Multicenter, Open Label, Phase II Study to Access Efficacy and Safety of Lucentis® Monotherapy (Ranibizumab 0.5 mg Intravitreal Injections) Compared With Lucentis® Plus Panretinal Photocoagulation (PRP) and PRP (Monotherapy) in the Treatment of Patients With High Risk Proliferative Diabetic Retinopathy
The purpose of this trial is to evaluate safety and to compare the efficacy of intravitreous injection of ranibizumab alone (0.5 mg), versus combination of intravitreous injection of ranibizumab (0.5 mg) plus panretinal photocoagulation, versus panretinal photocoagulation alone in the regression of retinal neovascularization in eyes with high-risk proliferative diabetic retinopathy.
Panretinal photocoagulation can cause regression of retinal neovascularization and reduce
the risk of severe vision loss in people with proliferative diabetic retinopathy. However,
this destructive treatment may be associated with side effects (such as: 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 proliferative diabetic
retinopathy and diabetic macular edema. Anti-vascular endothelial growth factor treatments
have been hypothesized as an alternative adjunctive treatment for the management of retinal
neovascularization and macular edema related with diabetic retinopathy.
There are a few reports of retinal traction detachment in patients with proliferative
diabetic retinopathy and fibrovascular proliferation (although it is not frequent). However,
from our clinical experience, we think that the risk of detachment only exists when there is
in place a fibrovascular proliferation with retinal traction previous to the injection.
We injected ranibizumab prior to surgery in patients with severe proliferative diabetic
retinopathy, that were submitted later to a posterior vitrectomy, to reduce
neovascularization and minimize the risk of an intraoperatory hemorrhage caused by the
manipulation of the fibrovascular membranes. In total, we already injected and submitted to
surgery 15 eyes with the above mentioned condition, with excellent results. The results of
the first 10 eyes were presented in the congress of the Portuguese Society of Ophthalmology
(2008).
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT01281098 -
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.
|
Phase 2 | |
| Completed |
NCT01941329 -
Prospective, Randomized, Multicentre, Open-label, Phase II / III Study to Assess Efficacy and Safety of Ranibizumab 0.5 mg Intravitreal Injections Plus Panretinal Photocoagulation (PRP) Versus PRP in Monotherapy in the Treatment of Subjects With High Risk Proliferative Diabetic Retinopathy.
|
Phase 2/Phase 3 |