Intravitreal Ranibizumab for Vitreous Hemorrhage Due to Proliferative Diabetic Retinopathy (N)
Vitreous HemorrhageProliferative Diabetic RetinopathyThis study is being conducted to determine if intravitreal injections of ranibizumab decrease the proportion of eyes in which vitrectomy is performed compared with saline injections in eyes presenting with vitreous hemorrhage from proliferative diabetic retinopathy.
Clinical Trial of Gene Therapy for Leber Congenital Amaurosis Caused by RPE65 Mutations
Leber Congenital AmaurosisThe purpose of this clinical trial is to examine the safety of gene therapy for Lebers Congenital Amaurosis (LCA) caused by RPE65 mutations using a recombinant adeno-associated virus serotype 2 (rAAV2) vector carrying the human RPE65 (hRPE65) gene. Recently, three independent short-term gene therapy studies in humans with LCA due to RPE65 mutations were published, suggesting that subretinal delivery of rAAV virus carrying the RPE65 gene is safe. As a secondary outcome, improvement in visual function was observed in seven of the first nine treated patients. The proposed study is a similar open label, Phase I clinical trial of uniocular subretinal rAAV2-hRPE65 administration to individuals with RPE65-associated retinal disease. Two cohorts of three subjects each and one cohort of four subjects will be included in this trial. Cohort 1 and 2 will consist of individuals 18 years of age and older and Cohorts 3 will consist of individuals 8 years of age and older. In cohort 2, a larger volume of vector will be administered. Enrollment in Cohort 3 will begin only after confirming the safety of rAAV2-hRPE65 administration in the older group of participants.
Intravitreal Bevacizumab for Diabetic Retinopathy
Severe NonproliferativeProliferative Diabetic Retinopathy1 moreBackground: to evaluate the 3-month efficacy of a single dose of intravitreal bevacizumab on the progression of severe non proliferative diabetic retinopathy, proliferative diabetic retinopathy and active photocoagulated diabetic proliferative by evaluation of ischemic areas and regression of retinal and disc neovasculrization. Methods: 40 patients were enrolled in a prospective, interventional study. Patients were treated with intravitreal bevacizumab 0.1ml (0.25mg). We evaluated visual acuity, neovascularization leakage points, capillary closure ischemic areas and macular edema by clinical examination and fluorescein angiography. A clinical examination was performed at baseline and days 1,14 and 30. Active leakage points were measured by fluorescein angiography at 30 days.
Anesthesia for Pars Plana Vitrectomy (PPV) With Insulin Needle
Retinal DisordersPeriocular blockade with 12.5 mm needle is as effective as block with 25 mm needle for patients undergoing Pars Plana Vitrectomy.
High Dose Intravitreal Ranibizumab for Recalcitrant Radiation Retinopathy
Radiation RetinopathyThis study investigates the use of a high dose anti-VEGF agent for the treatment of radiation retinopathy in those patients who have recalcitrant disease.
Diabetic Retinopathy Sulodexide Study
Diabetic RetinopathyThe aim of this phase 2 controlled placebo study is to assess the effectiveness of Sulodexide in the treatment of non proliferative (background) retinopathy in patients with Type 1 and Type 2 Diabetes Mellitus. This is a multicentre, double-blind, randomised study involving patients affected by non proliferative (background) diabetic mild to moderate retinopathy. This study will involve 130 patients (65 for each group). At baseline visit (T0), the Investigator will grade the ocular lesions due to diabetic retinopathy according to color fundus photographs and the fluorescein angiography examination. He will subsequently send the negatives of photographs and the images -or negatives when available- of fluorescein angiography to an off-site Assessor -unaware of the Investigator assessment- nominated to confirm the quality of the images and the grade of the lesions. After positive assessment of the Investigator, at T0 the eligible patient will be blindly allocated to one of the 2 treatment groups according to a computer-generated randomisation list provided by the Sponsor. The following treatments will be administered for 360 days: A (SULODEXIDE GROUP): 50 mg a day by oral route; B (PLACEBO GROUP): Sulodexide placebo at the same schedule and for the same lengths of time as group A. Before breaking the randomisation code at the end of the study, an independent off site assessor will evaluate the photographs according to the Airlie House Classification and following modification by Early treatment Diabetic Retinopathy Study (ETDRS) and fluorescein angiography according to ETDRS.
Green Laser Photocoagulation Study in Proliferative Diabetic Retinopathy
Diabetic RetinopathyTo Demonstrate that indigenous green laser produces similar treatment effect on the retina when compared with already available green laser.
Topic Antiinflammatory Therapy Added to Selective Photocoagulation in Macular Edema
Diabetic RetinopathyMacular EdemaThe purpose of this study is to determine the efficacy of ocular topic antiinflammatory therapy (sodic nepafenac at 0.1% or ketorolac at 0.5%) to treat center point thickness secondary to selective photocoagulation in diabetics with clinically significant macular edema.
Trial of Subretinal Injection of (rAAV2-VMD2-hMERTK)
Retinal DiseaseRetinitis PigmentosaThis study was to assess the safety of gene transfer via subretinal administration of rAAV2-VMD2-hMERTK in subjects with MERTK-associated retinitis pigmentosa (RP).
Intravitreal Long Acting Gas in the Prevention of Early Postoperative Vitreous Hemorrhage in Diabetic...
Diabetes MellitusDiabetic Retinopathy1 moreRecurrent vitreous hemorrhage after vitrectomy for complications of diabetic retinopathy is a common occurrence. The hemorrhage may appear within the first few weeks after surgery or months later. This complication may delay visual rehabilitation significantly and sometimes requires additional procedures or surgery, jeopardizing previous successful operation. The causes of bleeding are diverse. While evidence suggests fibrovascular proliferation from the sclerotomy sites or in the vitreous base may be an important source of recurrent vitreous hemorrhage, other origins of hemorrhage exist including lysed clot from residual vitreous skirt, injured retinal vessels from surgery, and incompletely removed fibrovascular tissues. The latter three conditions may be the major sources of early postoperative vitreous hemorrhage. We have shown that peripheral retinal cryotherapy along with cryo treatment at the sclerotomy sites may effectively reduce the incidence of fibrovascular proliferation at the inner surface of sclerotomy sites and prevent the late-onset recurrent vitreous hemorrhage. However, many patients still experience disturbing vitreous hemorrhage within the first two to three weeks after post-operative transient clear-up of the vitreous. We hypothesize that gas bubble within the vitreous cavity may mechanically temponade the fragile retinal vessels, and concentrate the coagulation factors in the vitreous cavity, allowing the integrity of vessel walls gradually recovers and thus preventing the occurrence of early postoperative recurrent vitreous hemorrhage. To test this hypothesis, a clinical study was undertaken to investigate the effect of long-acting gas infused into the vitreous cavity at the end of diabetic vitrectomy in the prevention of recurrent vitreous hemorrhage.