NCT00457145

Injected Ranibizumab to Treat Macular Telangiectasia Without New Blood Vessel Formation

Completed Phase 1 Last updated 2 July 2017

What this trial tests

Phase 1 trial testing Ranibizumab in Telangiectasia in 5 participants. Completed in 24 October 2007.

Timeline

27 March 2007

24 October 2007

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	5
Start date	27 March 2007
Estimated completion	24 October 2007
Sites	1 location across United States

Drugs / interventions tested

• Ranibizumab — full drug profile →

Conditions studied

• Telangiectasia — all drugs for Telangiectasia →

Sponsor

National Eye Institute (NEI)

Who can join

Adults 18 to 80, any sex, with Telangiectasia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This study will examine whether the drug ranibizumab is an effective treatment for macular telangiectasia, a condition in which existing blood vessels near the macula (the back part of the eye responsible for sharp central vision) become dilated and twisted, and new abnormal blood vessels may form under the retina. Both the existing dilated vessels, as well the new subretinal vessels can leak fluid and blood, distort the retina, and affect vision. This study will see if ranibizumab can slow or stop the leakage and growth of existing, dilated, macular vessels in cases where new vessel formation under the retina is absent.

Patients 18 years of age and older who have macular telangiectasia without new blood vessel formation may be eligible for this study. Visual acuity must be 20/40 or worse.

Participants receive at least four injections of ranibizumab into the eye over a 12-week period. After the fourth injection, additional injections may be given every 4 weeks for up to 1 year if the doctor determines that they may be of benefit. In addition to ranibizumab treatment, patients undergo the following procedures:

* Medical history and physical examination.
* Eye examination, including dilation of the pupils and measurement of the fluid pressure in the eye.
* Fluorescein angiogram: A yellow dye is injected into an arm vein and travels to the blood vessels in the eyes. Photographs of the retina are taken with a special camera that flashes a blue light into the eye. The photos show whether any dye has leaked from the vessels into the retina.
* Indocyanine green angiography: This procedure identifies feeder vessels that may be supplying the abnormal blood vessels. The test is similar to fluorescein angiography, but uses a green dye and flashes an invisible light.
* Autofluorescence imaging: This test examines how well the retina functions. The back of the eye is photographed with a bright light.
* Optical coherence tomography: This test measures retinal thickness. A light shined into the eye produces cross-sectional pictures of the retina. The measurements are repeated during the study to determine if retinal thickening is getting better or worse, or staying the same.
* Stereoscopic color fundus photography: The pupils are dilated and special photographs of the inside of the eye are taken to evaluate the retina and measure changes that occur over time. The camera flashes a bright light into the eye for each picture.
* Follow-up visits: The doctor evaluates the effects of the study treatment before and after each injection. Patients are contacted by phone 3 days after each injection to check on any treatment side effects. A final follow-up visit is scheduled 8 weeks after the last treatment.

Publications & conference data

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