Status:
COMPLETED
Ranibizumab Injections to Treat Macular Telangiectasia Without New Blood Vessel Growth
Lead Sponsor:
National Eye Institute (NEI)
Conditions:
Macular Telangiectasia
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
This study will examine whether the drug ranibizumab (Lucentis) can help prevent vision loss in people with macular telangiectasia, a condition in which new blood vessels grow in the retina at the bac...
Detailed Description
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 t...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- Participant must understand and sign the informed consent.
- Participant must be at least 18 years of age.
- Participant must have macular telangiectasia in both eyes.
- Participant must have vision loss of better than 20/400 in the study eye.
- Participant must have clear ocular media and adequate pupillary dilation to permit good quality stereoscopic fundus photography.
- 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 two months following the last dose of ranibizumab.
- EXCLUSION CRITERIA:
- Safety and toxicity of ranibizumab have not yet been investigated in children. Further, it is unlikely that younger participants will be able to comply with all examinations and intravitreal injections. Therefore, participants below the age of 18 will be excluded from participation in the study. This ocular condition is not commonly found in participants below the age of 18.
- Participant has neovascularization in either eye.
- History (within past five years) or evidence of severe cardiac disease (apparent in electrocardiogram abnormalities, clinical history of unstable angina, acute coronary syndrome, myocardial infarction, revascularization procedure within six months prior to baseline, atrial or ventricular tachyarrythmias requiring ongoing treatment).
- History of stroke within 12 months of study entry.
- History within the past 30 days of a chronic ocular or periocular infection (including any history of ocular herpes zoster).
- Current acute ocular or periocular infection.
- Any major surgical procedure within one month of study entry.
- Known serious allergies to fluorescein dye.
- Previous participation in a clinical trial (for either eye) involving anti-angiogenic drugs (pegaptanib, ranibizumab, bevacizumab, anecortave acetate, Protein Kinase C inhibitors, etc.).
- Previous intravitreal drug delivery (e.g., intravitreal corticosteroid injection or device implantation) in the study eye.
- History of vitrectomy surgery in the study eye.
- History of glaucoma filtering surgery in the study eye.
- History of corneal transplant in the study eye.
- Pregnancy (positive pregnancy test) or lactation and premenopausal women not using adequate contraception. The following are considered effective means of contraception: surgical sterilization or use of oral contraceptives, barrier contraception with either a condom or diaphragm in conjunction with spermicidal gel, an IUD, or contraceptive hormone implant or patch.
Exclusion
Key Trial Info
Start Date :
May 21 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 24 2011
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT00685854
Start Date
May 21 2008
End Date
March 24 2011
Last Update
July 2 2017
Active Locations (1)
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1
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892