NCT00685503

Ranibizumab Injections to Treat Macular Telangiectasia With New Blood Vessel Growth

Completed Phase 1 Last updated 2 July 2017

What this trial tests

Phase 1 trial testing Ranibizumab in Neovascularization in 1 participant. Completed in 12 April 2011.

Timeline

21 May 2008

Primary endpoint
12 April 2011

12 April 2011

Quick facts

Lead sponsor	National Eye Institute (NEI)
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	1
Start date	21 May 2008
Primary completion	12 April 2011
Estimated completion	12 April 2011
Sites	1 location across United States

Drugs / interventions tested

• Ranibizumab — full drug profile →

Conditions studied

• Neovascularization — all drugs for Neovascularization →

Sponsor

National Eye Institute (NEI)

Who can join

18 and older, any sex, with Neovascularization. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.