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Ranibizumab Injections to Treat Macular Telangiectasia With New Blood Vessel Growth

NCT00685503 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 1

Last updated 2017-07-02

No results posted yet for this study

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 back of the eye and can leak. Such changes in blood vessels are seen in other diseases associated with changes in a body chemical called vascular endothelial growth factor (VEGF). Ranibizumab is an anti-VEGF drug that is effective in treating another eye disease, age-related macular degeneration, with similar changes in eye blood vessels.

People 18 years of age and older with macular telangiectasia in both eyes and new blood vessel growth in at least one eye may be eligible for this study. They must have vision better than 20/400 in the study eye.

Participants undergo the following procedures:

* Ranibizumab injections in the study eye at least four times over 12 weeks. Depending on the response to treatment and the side effects, additional injections may be given every 4 weeks for up to 1 year. The eye is numbed before the injection and the eye area is cleaned with an antiseptic. Antibiotic drops are used for 3 days following the injection to prevent infection.
* Evaluations before starting treatment, at the time of each injection, and 8 weeks after the last treatment:

* History and physical examination.
* Eye examination with dilation, microperimetry and photography: The eye examination measures visual acuity, eye pressure and eye movements. For the microperimetry test, subjects sit in front of a computer screen and press a button when they see a light on the screen. Measurements and photographs of the retina are also taken.
* Fluorescein and indocyanine green angiography to examine the blood vessels in the eye: A dye called fluorescein or indocyanine green is injected into a vein in the arm. The dye travels through the veins to the blood vessels in the eyes. A camera takes pictures of the dye as it flows through the blood vessels.
* Pregnancy test: Women who are able to become pregnant have a urine pregnancy test before each ranibizumab injection.

Conditions

  • Neovascularization

Interventions

DRUG

Ranibizumab

Sponsors & Collaborators

  • National Eye Institute (NEI)

    lead NIH

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-05-21
Primary Completion
2011-04-12
Completion
2011-04-12

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00685503 on ClinicalTrials.gov