Active clinical trials for "Retinal Diseases"

The purpose of this study is to evaluate the role, the safety and the effectiveness of Intravitreal Bevacizumab injections as an adjunct to vitrectomy in the management of severe proliferative diabetic retinopathy.

Patients suffering from hereditary retinal degeneration receive a retinal implant to restore sight. Subretinal implant "ON" results in significant visual acuity improvement, when compared to "OFF" condition.

The purpose of this study is to determine the efficacy and safety of topic ketorolac in treatment for center point thickness secondary to panphotocoagulation in proliferative diabetic retinopathy.

Objective: Diabetic macular edema (DME) is a frequent manifestation of diabetic retinopathy, a leading cause of blindness in the United States. The only proven treatment for DME is laser photocoagulation. Sirolimus has been shown to inhibit the production, signaling and activity of many growth factors relevant to the development of diabetic retinopathy. Therefore, this study will investigate the safety and efficacy of multiple sirolimus injections in patients with DME. Study Population: Eligibility criteria include central macular thickening > 260 microns and visual acuity 20/32 or worse in one or both eyes. Design: Five participants will be enrolled into this open-label pilot study. After receiving a 20 μL (440 μg) subconjunctival injection in the study eye at baseline and Month 2, the participants will be re-evaluated every two months for at least one year for possible additional injections. During follow-up, participants will not undergo re-injection if they show significant clinical improvement or treatment success, defined as no intraretinal fluid or cysts present on optical coherence tomography (OCT) OR 100% reduction in excess retinal thickness over 260 microns on OCT OR no leakage on fluorescein angiography (FA). Beginning at Month 4, participants will be assessed for treatment failure, defined as loss of 15 or more letters of vision compared to baseline at two consecutive visits OR a 50% or greater increase in total retinal thickness as measured by OCT at two consecutive visits. Individual participants deemed treatment failures will continue receiving sirolimus injections, but will be allowed to receive focal laser therapy for any amenable leaking microaneurysms at Month 4. Beginning at Month 6, focal laser therapy will be permitted for both treatment failures and participants who do not meet the criteria of a treatment success. Participants will have the option of continuing treatment until a common termination date of one year. Outcome Measures: The primary outcome is the change in visual acuity in the study eye at six months compared to baseline. Secondary outcomes include changes in visual acuity in the study eye at one year as compared with baseline, changes in retinal thickness as measured by OCT and changes in fluid leakage in the macula as demonstrated by FA at six months, one year and throughout the study period in the study and fellow eyes. Safety outcomes include number and severity of systemic and ocular toxicities, adverse events and infections, and the number of participants withdrawn from study therapy.

Treatment of diabetic macular edema with perifoveal focal/grid laser coagulation was found to be effective saving the visual acuity only in 50% of patients and only 3-14% of treated patients had an improved visual acuity postoperatively. The decent results of lasercoagulation are associated with potential side effects, as focal scotomas, change of color discrimination and development of epiretinal gliosis. The frequency of perifoveal laser treatments is anatomically limited in case of diabetic macular edema: after application of about 350 coagulates there is no possibility to repeat the laser treatment perifoveolar without creating confluent lasercoagulates and causing significant scotomas. In case of persistence of edema in spite of complete perifoveal grid coagulation, no standard therapy exists. Some previous studies investigated the effect of steroids in patients with diabetic macular edema unresponsive to grid laser photocoagulation, but the benefit on the visual acuity was only temporary and the intravitreal application was associated with significant side effects as cataract progression (up to 50%) and ocular hypertension (up to 20%). In the Diabetic Retinopathy Study the 4-years rate for severe vision loss in patients with high-risk retinopathy was 20.4 %. In cases of proliferative retinopathy, panretinal (scatter) photocoagulation can reduce the risk for development of high-risk retinopathy by 50% over 6 years. When panretinal lasercoagulation is initiated, about 2000 laser spots are equally distributed in all four quadrants. Since panretinal photocoagulation bares risks like loss of field of vision, central vision reduction and loss of colour vision, this treatment can not be continued unlimited. In cases of persisting neovascularisations in spite of panretinal photocoagulation, no evidence based therapy exists. There is a high risk for intravitreal bleeding, rubeosis, secondary glaucoma with severe vision loss. When fibrovascular proliferation leads to retinal detachment, vitreo-retinal surgery might be indicated. Now we know that vascular endothelial growth factor (VEGF) is the major angiogenic stimulus responsible for increase of vasopermeability, cellproliferation and angiogenesis in diabetic retinopathy (DRP). Several studies, evaluating VEGF levels in vitreous, have indicated a role for VEGF in diabetic macular edema: vitreous samples of patients with diabetic macular edema contain elevated VEGF concentration and VEGF injected in experimental studies results in breakdown of the blood-retina barrier. There is increasing evidence for a therapeutic role of anti-VEGF drugs not only in age-related macular degeneration but also in other diseases as in diabetic macular edema. Intravitreal injections have become the most favored treatment procedure for administering anti-VEGF drugs. The side effects and the decent results of laser treatment on the visual acuity in diabetic macular edema led to studies using anti-VEGF therapy. Unpublished study results on the aptamer pegaptanib (Macugen™) are promising. A study using the antibody fragment Ranibizumab (Lucentis™) in patiens with diabetic macula edema is in progress. Ranibizumab is now approved to be used as an intravitreal injection. Currently there is one additional anti-VEGF drug already on the market: Bevacizumab (Avastin™), which has approved as intravenous infusion for the treatment of metastatic colo-rectal cancer. Previous studies have shown that systemic use of Bevacizumab (Avastin™) can obtain very promising results on patients with choroidal neovascularisation (CNV) by age-related macular degenetration. This drug, a monoclonal full-length antibody, designed to bind all isoforms of VEGF is a large molecule. But case reports in patients with CNV caused by age-related macular degeneration and with macular edema from central retinal vein occlusion indicate that intravitreally given Bevacizumab (Avastin™) is effective in diseases originating from the choroids and the retina, too. These findings imply a sufficient penetration of the retina by Bevacizumab (Avastin™). Based on these new findings and the important role of VEGF in diabetic retinopathy, we propose a pilot study for treatment of persistent diabetic macular edema or persisting active neovascularistaions following lasercoagulation with intravitreally administered Bevacizumab (Avastin™) or Ranibizumab (Lucentis™).

The purpose of the study is to find out which is a better treatment for diabetic macular edema (DME): laser alone, laser combined with an intravitreal injection of triamcinolone, laser combined with an intravitreal injection of ranibizumab, or intravitreal injection of ranibizumab alone. At the present time, it is not known whether intravitreal steroid or anti-vascular endothelial growth factor (anti-VEGF) injections, with or without laser treatment, are better than just laser by itself. It is possible that one or both of the types of injections, with or without laser treatment, will improve vision more often than will laser without injections. However, even if better vision outcomes are seen with injections, side effects may be more of a problem with the injections than with laser. Therefore, this study is conducted to find out whether the benefits of the injections will outweigh the risks.

The purpose of this study is to determine whether preoperative intravitreal bevacizumab is effective in reducing intra-operative and postoperative bleeding in diabetic patients submitted to pars plana vitrectomy for vitreous hemorrhage.

In this study we intend to evaluate the outcome of intravitreal avastin on improving the visual acuity and macular edema and late complications of BRVO like NVD and NVE

This study will evaluate the clinical efficacy of intra-vitreal injections of Ranibizumab (Lucentis) in the treatment of Diabetic Macular Edema as compared to grid/focal laser.

The purpose of this study is to assess the efficacy of intravitreous injections of Vitrase to induce posterior vitreous detachment(PVD) in subjects with moderate to severe non-proliferative diabetic retinopathy.