Phase 2
N=20
Lucentis in Advanced Macular Degeneration
Macular Degeneration
Bottom Line
View on ClinicalTrials.gov: NCT00896779 ↗Enrolled (actual)
20
Serious AEs
0.0%
Results posted
May 2015
Primary outcome: Primary: Mean Change in Visual Acuity — 15.0; 5.6 letters — p=0.02
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- ranibizumab (Drug)
- Age
- Adult, Older Adult · 50+ yrs
- Sex
- All
- Sponsor
- Steven R. Sanislo
- Primary completion
- Sep 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Change in Visual Acuity |
15.0; 5.6 | 0.02 sig |
Summary
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.
Eligibility Criteria
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).
Data sourced from ClinicalTrials.gov (NCT00896779). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.