A cohort study provides the opportunity to collect data prospectively using a standardized protocol to assess the potential benefits and risks of vitrectomy. The results can be used to determine whether proceeding with a randomized trial has merit and what the design of the trial should be. If a randomized trial is to be conducted, the results plus the cohort study experience can be used to help design the RCT protocol.
Purpose: To determine the incidence and extent of macular edema following scatter laser photocoagulation surgery using optical coherence tomography OCT in eyes without macular edema prior to scatter laser photocoagulation, and to explore whether the incidence and extent of macular edema varies according to the number of sittings included in the treatment regimen. Design: Prospective, multi-center nonrandomized clinical trial. Number of patients: Approximately 1, patients will be enrolled in order to follow patients.
Design: Prospective, multi-center observational study. The study consists of a baseline phase and follow-up phase. Purpose: Determine whether ruboxistaurin can slow the progression of DME. Information: Retina Associates of Cleveland, Purpose: Determine whether intravitreal triamcinolone at doses of 1 mg or 4 mg provides greater benefit, with an acceptable safety profile, than macular laser in the treatment of DME.
Both eyes eligible: 1 eye randomized to laser, the other to 1 mg or 4 mg of triamcinolone. Purpose: Myopic Macular Degeneration MMD is a progressive eye disease caused by the thinning of the retina and underlying support tissue as the eye is stretched and elongated.
This condition can result in tears in the tissues under the center of vision macula and bleeding can occur, which may lead to vision loss. The purpose of this study is to evaluate the safety and dose response of Combretastatin A4 Phosphate CA4P , an investigational drug, in patients with active choroidal neovascularization secondary to myopic macular degeneration.
Design: This phase 2 clinical trial is an open label, dose-ranging, international multicentered study. Drug is administered intravenously.
Exclusion Criteria: Patients must not be currently pregnant, planning a pregnancy, patients must not have received any previous experimental procedure in either eye or have used any investigational drug or treatment within 30 days prior to enrolling in this trial. Design: Phase 3, randomized, controlled, double-masked, multi-center, comparative, dose finding.
Study: The Standard Care vs. Purpose: To compare the effectiveness and safety of standard care to intravitreal injection s of triamcinolone for treating macular edema swelling of the central part of the retina associated with CRVO and BRVO.
Design: Multicenter, randomized, phase 3 trial. Eligible patients within each of these 2 disease entities are randomized in a ratio to 1 of 3 groups: standard care, intravitreal injection s of 4 mg of triamcinolone acetonide, or intravitreal injection s of 1 mg of triamcinolone acetonide. Enrolled patients are followed for 3 years. There was no rule book for how to deal with this.
The investigators tasked with discovering what went wrong: "This was treated as a crime scene. Something could have been tampered with, sabotaged, poisoned and that these folk might have been the victims of such foul play.
This dramatic, thought-provoking science documentary tells the story in gripping detail. However, what happens when a novel drug has effects that have not been encountered before? This was the case in a clinical trial carried out at Northwick Park Hospital in March Six volunteers offered to help in the testing of a new drug, called TGN, to treat leukaemia and also diseases like rheumatoid arthritis.
However, within 90 minutes of receiving the experimental drug they were writhing in agony as the drug had caused reactions never seen in a clinical trial before, nor in any of the pre-clinical safety tests. Within 12 hours all were in intensive care which lasted up to 16 days as doctors fought to control the symptoms. In the end, all six volunteers survived.
However, one of them lost his toes and fingers and all of them may face health complications in the future as a consequence of life threatening "cytokine storm" they experienced. So what went wrong? Was the drug the same as the material that appeared perfectly safe in preclinical trials?
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