Trial Search Results

Lucentis in Advanced Macular Degeneration

Patients with low vision (visual acuity 20/400 or worse) were excluded from the large Phase III ranibizumab clinical trials. It is not known if treatment with ranibizumab results in improved visual function in such patients.Since ranibizumab has been shown to be the most effective therapy for exudative macular degeneration we propose to treat all patients in this study with monthly ranibizumab intravitreal injections.

Patients will be assigned to one of two groups by the flip of a coin. Group #1 for "heads" and Group #2 for "tails".

Group #1 patients will be treated for 3 monthly injections of 0.5 mg of ranibizumab and then as needed therapy.

Group #2 will be treated with 6 monthly injections of 0.5 mg of ranibizumab and then as needed therapy.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Steven R. Sanislo

Collaborator: Genentech, Inc.

Stanford Investigator(s):

Intervention(s):

  • Drug: ranibizumab

Phase:

Phase 2

Eligibility


Inclusion Criteria:

Subjects will be eligible if the following criteria are met:

   - Ability to provide written informed consent and comply with study assessments for the
   full duration of the study.

   - Age > 50 years.

   - Low vision AMD patients with a VA of 20/400 or worse.

   - Evidence of active exudation as manifested by subretinal or intraretinal fluid on OCT
   or fresh appearing subretinal hemorrhage on fundus examination.

Exclusion Criteria:

Subjects who meet any of the following criteria will be excluded from this study:

   - Pregnancy (positive pregnancy test) or lactation.

   - 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.

   - Any other condition that the investigator believes would pose a significant hazard to
   the subject if the investigational therapy were initiated.

   - Participation in another simultaneous medical investigation or trial.

   - Concurrent eye disease in the study eye that could compromise visual acuity (e.g.,
   diabetic retinopathy, advanced glaucoma).

Ages Eligible for Study

50 Years - N/A

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Patricia Mattio
6507216884
Not Recruiting