Participation in clinical trials is an indicator of best practice models. Entities funding these important studies do not award trial site status to just any practice. Coordinators for trials apply rigorous evaluation standards to potential investigating physicians and participating sites prior to considering inclusion.
From the patient's perspective, clinical trials provide many benefits. Great attention is directed to those enrolled in a trial, and participation typically incorporates a significant safety net for rescue therapy should a protocol not prove effective clinically. The number of people that may benefit from information learned through clinical trials is untold. Medicine would be hopelessly behind were it not for these physician and patient supported studies.
Age-Related Macular Degeneration, Retinal Vein Occlusion, Diabetic Macular Edema
A Phase IV, Open Label, Multi-center Study to Assess the Effect of Intravitreal Injections of Macugen (Pegaptanib Sodium Injection)Administered Every 6 Weeks for 48 Weeks on the Corneal Endothelium. Due to the lack of information generated in the pivotal phase III trials assessing potential effects of intravitreal injections of Macugen (pegaptanib sodium injection) on the corneal endothelium, the FDA requested clinical information from a 1-year (minimum) clinical study to support that there are no adverse effects on the corneal endothelium following intravitreal injections of Macugen.
Sponsor:Valeant Pharmaceuticals International, Inc.
ClinicalTrials.gov Identifier: NCT 01573572
Patient must be 50 years of age or older and diagnosed with subfoveal neovascular Age-Related Macular Degeneration, Diabetic Macular Edema, or Retinal Vein Occlusion. Best corrected visual acuity in the study eye between 20/20 and 20/400 using a Snellen chart.
Key Exclusion Criteria: Unilateral ocular blunt trauma within one year of enrollment and no greater than 5% difference in central endothelial cell density between the 2 eyes, intraocular surgery (cataract surgery and surgery for glaucoma without tube shunt or mini-shunt) within one year of enrollment, Anterior segment laser surgery (laser trabeculoplasty) performed within one year of enrollment, Glaucoma tube-shunt surgery, Previous history of corneal transplant in the study or non-study eye, Presence of vitreous macular traction, Previous therapeutic radiation in the region of the study eye, Any treatment with an investigational agent in the past 30 days for any condition, Severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation.
Enrollment status: CLOSED
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Phase 2 Double-Masked, Placebo-Controlled Study to Assess the Safety and Efficacy of Subcutaneously Administered AKB-9778 15mg Once Daily or 15mg Twice Daily for 12 Months in Patients With Moderate to Severe Non-Proliferative Diabetic Retinopathy.
ClinicalTrials.gov Identifier: NCT03197870
Patient must be 18 through 80 years of age (inclusive), Subjects with moderate to very severe Non-proliferative diabetic retinopathy, No evidence of central involved Diabetic Macular Edema, ETDRS BCVA letter score ≥ 70 (Snellen 20/40 or better)
Key Exclusion Criteria: Ocular disease other than DR that may cause substantial reduction in visual acuity, including iris neovascularization, retinal detachment, visually significant epiretinal membrane, vitreous hemorrhage or fibrosis, ocular inflammation (uveitis), other retinal inflammatory or infectious diseases, Evidence of neovascularization on clinical examination or imaging, Hemoglobin A1C (HbA1C) ≥ 12.0% at Screening, Severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation.
Enrollment status: OPEN
For more information on this trial