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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
54
Center for Clinical Trials - Association for Innovation and Biomedical Research on Light and Image
Coimbra, Portugal
Espaço Médico de Coimbra
Coimbra, Portugal
ALM Oftalmolaser
Lisbon, Portugal
Instituto de Retina de Lisboa
Lisbon, Portugal
Instituto de Oftalmologia Dr. Gama Pinto
Lisbon, Portugal
Instituto CUF
Porto, Portugal
Hospital de São João
Porto, Portugal
Regression of neovascularization
To demonstrate superiority of one of the treatment arms: ranibizumab 0.5 mg monotherapy, panretinal photocoagulation monotherapy or combination therapy (ranibizumab 0.5 mg plus panretinal photocoagulation) over a 12-month treatment period in the regression of neovascularization.
Time frame: 12-month treatment
Changes from baseline in Best-Corrected Visual Acuity
Best-Corrected Visual Acuity will be assessed during the trial (Baseline, Month 3, Month 6 and Month 12).
Time frame: 12-month treatment
Changes from baseline in macular retinal thickness by Optical Coherent Tomography
Optical Coherent Tomography will be assessed during the trial (Baseline, Month 3, Month 6 and Month 12).
Time frame: 12-month treatment
Recurrence of neovascularization
To assess if there is recurrence of neovascularization.
Time frame: 12-month treatment
Number of treatments needed
To analyse the number treatments given to each subject during the the 12-month treatment.
Time frame: 12-month treatment
Additional focal or grid laser for Diabetic Macular Edema
To assess the number of patients that received additional focal or grid laser for Diabetic Macular Edema.
Time frame: 12 month treatment
Adverse events
Drug safety profile.
Time frame: 12-month treatment
Need for vitrectomy due to occurrence of vitreous hemorrhage or retinal detachment relative to the three treatment arms.
To assess the number of subjects who needed vitrectomy due to occurrence of vitreous hemorrhage or retinal detachment relative to the three treatment arms.
Time frame: 12-month treatment
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