Injected Ranibizumab to Treat Macular Telangiectasia Without New Blood Vessel Formation

Launched by NATIONAL EYE INSTITUTE (NEI) · Apr 4, 2007

Keywords

ClinConnect Summary

Retinal telangiectasis is a group of rare, idiopathic retinal vascular anomalies affecting the retinal capillaries in which irregular capillary dilation and incompetence occur in the macula. This is the former group 2 in the Gass classification of idiopathic juxtafoveal telangiectasia in which fluorescein angiography showed leakage with capillary dilation. These patients typically are diagnosed in their fifth or sixth decade of life. Both sexes may be affected. Minimal exudation, superficial retinal crystalline deposits, and right-angle venules characterize this disorder. As the disease pro...

Gender

ALL

Eligibility criteria

• * INCLUSION CRITERIA:
• • 1. Participant must understand and sign the informed consent.
• • 2. Participant must be at least 18 years of age.
• • 3. Participant must have macular telangiectasia in both eyes.
• • 4. Participant must have vision loss of 20/40 or worse.
• • 5. Participant must have clear ocular media and adequate papillary dilation to permit good quality stereoscopic fundus photography.
• • 6. All women of childbearing potential must have a negative urine pregnancy test at baseline, and be willing to undergo testing immediately prior to each injection and monthly for at least 2 months following the last dose of ranibizumab.
• • 7. Women of child-bearing potential who are sexually active and men who are sexually active are required to use two forms of birth control during the course of the study.
• EXCLUSION CRITERIA:
• • 1. Participant has neovascularization in either eye.
• • 2. History (within past 5 years) 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 tachyarrythmias requiring ongoing treatment).
• • 3. History of stroke within 12 months of study entry.
• • 4. History within the past five years of a chronic ocular or periocular infection (including any history of ocular herpes zoster).
• • 5. Current acute ocular or periocular infection.
• • 6. Any major surgical procedure within one month of study entry.
• • 7. Known serious allergies to fluorescein dye.
• • 8. Previous participation in a clinical trial (for either eye) involving anti-angiogenic drugs (pegaptanib, ranibizumab, bevacizumab, anecortave acetate, Protein Kinase C inhibitors, etc.).
• • 9. Previous intravitreal drug delivery (e.g., intravitreal corticosteroid injection or device implantation) in the study eye.
• • 10. History of vitrectomy surgery in the study eye.
• • 11. History of glaucoma filtering surgery in the study eye.
• • 12. History of corneal transplant in the study eye.