Ranibizumab in Idiopathic Parafoveal Telangiectasia (RIPT) Trial

• Status: Completed
• Trial end date: 2008-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Johns Hopkins University
• Collaborator: Genentech, Inc.
• Treatments: Ranibizumab

Criteria

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.