Lucentis in Advanced Macular Degeneration

Part of paid clinical trials in San Francisco, California.

Sponsor
Steven R. Sanislo
Study ID
NCT00896779
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
50 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • ranibizumab — DRUG
    Group 1 - 0.5mg intravitreal injection every month for 3 months then as needed for 12 months Group 2 -0.5mg intravitreal injection every month for 6 months then as needed for 12 months

Study Details

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.

Key Dates

First listed
May 12, 2009
Start date
Oct 31, 2009
Status verified
Jun 2015
Primary completion
Sep 30, 2013
Completion
Sep 30, 2013

Study Design

Enrollment
20 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Other: ranibizumab Group 1
    Group 1: 3 monthly injections of 0.5mg then prn
  • Other: ranibizumab Group 2
    Group 2: 6 monthly injections of 0.5 mg then prn

Primary Outcome Measure

Mean Change in Visual Acuity [ Time Frame: 12 months ]

Locations (2)

FacilityCityStateZIPSite coordinators
California Pacific Medical CenterSan FranciscoCalifornia94107-
Stanford University School of MedicineStanfordCalifornia94305-

Find similar trials in San Francisco, CA

By condition
Age-related macular degeneration
By specialty
OphthalmologyRetina
By research site
California Pacific Medical Center· San Francisco, CAStanford University School of Medicine· Stanford, CA

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