Protocol Number: 08-EI-0146

Title:

Pilot Study of Intravitreal Injection of Ranibizumab for Macular Telangiectasia with Neovascularization (MACTEL 1)

Number:

08-EI-0146

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.

Sponsoring Institute:

National Eye Institute (NEI)

Recruitment Detail

Type: Participants currently recruited/enrolled

Gender: Male & Female

Referral Letter Required: Yes

Population Exclusion(s): Children

Eligibility Criteria:

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 neovascularization in the study eye.

-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 2 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.

-History (within past five years) of a myocardial infarction or cerebrovascular accident 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.

Special Instructions:

Currently Not Provided

Keywords:

Macular Telangiectasia

Vascular Endothelial Growth Factor

Ranibizumab

Neovascularization

Recruitment Keyword(s):

Macular Telangiectasia

Condition(s):

Neovascularization

Investigational Drug(s):

Ranibizumab

Investigational Device(s):

None

Intervention(s):

Drug: Ranibizumab

Supporting Site:

National Eye Institute

Contact(s):

Patient Recruitment and Public Liaison Office
Building 61
10 Cloister Court
Bethesda, Maryland 20892-4754
Toll Free: 1-800-411-1222
TTY: 301-594-9774 (local),1-866-411-1010 (toll free)
Fax: 301-480-9793

Electronic Mail:prpl@mail.cc.nih.gov

Citation(s):

Aiello LP, Avery RL, Arrigg PG, Keyt BA, Jampel HD, Shah ST, Pasquale LR, Thieme H, Iwamoto MA, Park JE, et al. Vascular endothelial growth factor in ocular fluid of patients with diabeticretinopathy and other retinal disorders. N Engl J Med. 1994 Dec 1;331(22):1480-7.

Amin R, Puklin JE, Frank RN. Growth factor localization in choroidal neovascular membranes of age-related macular degeneration. Invest Ophthalmol Vis Sci. 1994 Jul;35(8):3178-88.

Boulton M, Foreman D, Williams G, McLeod D. VEGF localisation in diabetic retinopathy. Br J Ophthalmol. 1998 May;82(5):561-8.

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