Telangiectasia Clinical Trial
Official title:
Ranibizumab in Idiopathic Parafoveal Telangiectasia (RIPT) Trial
Verified date | November 2012 |
Source | Johns Hopkins University |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
This research is being done to look at the effects of an experimental drug, ranibizumab, for the treatment of a condition called "idiopathic parafoveal telangiectasia" or IPT. IPT is caused by swelling in the retina (the light sensitive tissue in the back of the eye) due to leaky blood vessels in this area. Swelling in the retina can lead to blurry vision.
Status | Completed |
Enrollment | 10 |
Est. completion date | December 2008 |
Est. primary completion date | September 2007 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Subjects will be eligible if the following criteria are met: 1. Ability to provide written informed consent and comply with study assessments for the full duration of the study. 2. Age > 18 years 3. Diagnosis of bilateral IPT with macular edema documented on OCT and no evidence of choroidal neovascularization. 4. Best corrected visual acuity of better or equal to 20/200 in both eye Exclusion Criteria: - Subjects who meet any of the following criteria will be excluded from this study: 1. Known hypersensitivity to humanized monoclonal antibodies 2. History (within past 6 months) or evidence of severe cardiac disease (apparent in electrocardiogram abnormalities, clinical history of unstable angina, acute coronary syndrome, myocardial infarction, revascularization procedure within 6 months prior to baseline, atrial or ventricular tachyarrhythmias requiring ongoing treatment). 3. History of stroke within 6 months of study entry. 4. Current acute ocular or periocular infection. 5. Any major surgical procedure within one month of study entry. 6. Known serious allergies to fluorescein dye. 7. Previous participation in a clinical trial (for either eye) involving anti-angiogenic drugs (pegaptanib, ranibizumab, anecortave acetate, Protein Kinase C inhibitors, etc) within last 6 months. 8. Previous intravitreal drug delivery (e.g., intravitreal corticosteroid injection or device implantation) in the study eye within the last 6 months. 9. History of subfoveal laser treatment in the study eye. 10. History of other visually-limiting conditions such as optic neuropathy, amblyopia, choroidal neovascularization due to causes other than IPT in the study eye. 11. Ocular inflammation (including trace or above) in the study eye. 12. Inability to comply with study or follow up procedures. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | The Wilmer Eye Institute at Johns Hopkins | Baltimore | Maryland |
Lead Sponsor | Collaborator |
---|---|
Johns Hopkins University | Genentech, Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Proportion of subjects with improvement of 15 or more letters of best corrected visual acuity from baseline to 3 months on an Early Treatment Diabetic Retinopathy visual acuity chart measured at 4 meters | 3 months | No | |
Secondary | Retinal changes on ophthalmoscopy | 3 months | No | |
Secondary | Retinal thickness measured by Optical Coherence Topography (OCT) | 3 months | No | |
Secondary | Fluorescein leakage on fluorescein angiography | 3 months | No | |
Secondary | Complications related to drug or its administration | 12 months after last injection | Yes |
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