A Multicentre Randomised Clinical Trial of Laser Treatment Plus Intravitreal Triamcinolone for Diabetic...
Diabetic Macular OedemaThis study is likely to identify an improved and economical treatment for diabetic macular oedema, one of the commonest causes of blindness both in Australia and the rest of the world.The specific aims of the study are to test the following hypotheses: That intravitreal triamcinolone followed by laser treatment results in a greater improvement in visual acuity than placebo followed by laser treatment of eyes with macular oedema secondary to diabetes; That intravitreal triamcinolone followed by laser treatment results in greater degree of resolution of macular oedema than placebo followed by laser treatment of eyes with macular oedema secondary to diabetes; That intravitreal triamcinolone followed by laser treatment results in a reduced requirement for further laser treatment to control diabetic macular oedema than placebo followed by laser treatment; That intravitreal triamcinolone followed laser has a manageable and acceptable safety profile in eyes with diabetic macular edema.
Intravitreal v. Sub-tenon Injections of Triamcinolone Acetonide for Macular Edema in Retinal Disorders...
Macular DegenerationRetinal Vein Occlusion1 moreThe use of intravitreal injections of corticosteroid (triamcinolone acetonide) appears to be a promising treatment for a variety of ocular diseases associated with inflammation. To date, the only drug available, "Kenalog-40 Injection" produced by Bristol Myers Squibb, has not been formulated for intraocular use. The purpose of this study is to evaluate the long-term safety and potential efficacy of novel intravitreal injections of a preservative-free formulation of triamcinolone acetonide (TAC-PF) at two dosage levels (4 mg and 8 mg) compared to anterior sub-tenon injections of TAC-PF at 20 mg. The study will be a masked, randomized Phase I study that will enroll 120 participants with one of the following diseases: age-related macular degeneration (AMD), diabetic macular edema (DME), central retinal vein occlusion (CRVO), branch retinal vein occlusion (BRVO), or any other retinal disease with associated macular edema. At least 21 participants will be enrolled in the four designated disease strata: AMD, DME, CRVO, and BRVO. The remaining 36 participants may have one of these diseases or may be enrolled with another retinal disease. Within each disease strata, at least seven participants will be randomized to each dosing group. The participants will be randomly assigned to one of the three treatment groups. The primary outcome will be an assessment of post-injection intraocular toxicity-related events during the 3-year follow-up, including cataract formation, development of glaucoma, and any adverse event preventing retreatment. The secondary outcomes will be an improvement in best-corrected visual acuity (BCVA, EVA) and decreases in retinal thickening and area of leakage, from baseline to year 1.
A Study of the Safety and Efficacy of a New Treatment for Macular Edema Resulting From Retinal Vein...
Macular EdemaRetinal Vein OcclusionThis study will evaluate the safety and efficacy of an intravitreal implant of dexamethasone for the treatment of macular edema associated with retinal vein occlusion.
A Study of the Safety and Efficacy of a New Treatment for Diabetic Macular Edema
Diabetic Macular EdemaThis study will evaluate the safety and efficacy of an intravitreal implant of dexamethasone for the treatment of diabetic macular edema.
Evaluation of Inflammation and Pain Post Injection of Ranibizumab vs Aflibercept in Patients With...
Diabetic Macular EdemaThis study is designed to compare the post injection inflammation and pain seen after intravitreal injections of ranibizumab 0.3mg and aflibercept 2.0mg in patients with DME. The investigators will be evaluating patients (1-7 days) post injections for: 1. Intraocular inflammation (defined as anterior chamber and/or vitreous cells 2. Pain (as measured on a standardized pain scale).
Efficacy and Safety of Aflibercept as Mono-therapy in Treat and Extend Regimen for DME Patients...
Center-involved Diabetic Macular EdemaPhase IIIb, multicenter, open-label, prospective, interventional study to assess the potential benefit of Aflibercept treatment administered IVT at a dosage of 2 mg with five monthly loading doses and then treat and extend over 48 weeks, with the primary endpoint as BCVA assessed at Week 52.
Sub-macular Injection of Ranibizumab as a New Surgical Treatment for Refractory Diabetic Macular...
Diabetic Macular EdemaThe best treatment strategy for refractory DME is not known, options include switching between anti-VEGF agents, corticosteroids, and vitrectomy. In this study, authors describe a new surgical technique for the treatment of refractory non tractional DME. The technique consists of vitrectomy with ILM peeling with subretinal injection of Ranibizumab.
Early Anatomical, Physiological, and Clinical Changes in Diabetic Macular Edema After Intravitreal...
Diabetic Macular EdemaDiabetic Retinopathy1 moreThis is a one month pre post intervention study. Subjects with diabetic macular edema were given intravitreal anti VEGF (Aflibercept) injection. Central retinal thickness, macular electrophysiology, and visual acuity were observed one week and one month after injection was given to the eye to describe early anatomical, physiological, and clinical changes. We hypothesized that changes to these outcomes can be found and documented.
Performance Assessment Tests in Working Individuals With DME Following Treatment With Ranibizumab...
Diabetic Macular EdemaPerformance assessment testing may be a useful tool to evaluate the impact of ranibizumab on day-to-day visual function in patients with Diabetic Macular Edema (DME).
Bevacizumab and Peripheral Retinal Changes on Wide Field Angiography in Diabetic Macular Edema
Non-proliferative Diabetic RetinopathyProliferative Diabetic Retinopathy1 moreUltra-wide field fluorescein angiography can detect the response of anti VGEF therapy such as Avastin on retinal ischemia in the setting of diabetic macular edema.