Lucentis for Age-related Macular Degeneration Pigment Epithelial Detachments

Part of paid clinical trials in San Francisco, California.

Sponsor
Pacific Eye Associates
Study ID
NCT00590694
Phase
PHASE2/PHASE3
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • ranibizumab — DRUG
    0.5mg injection monthly according to protocol for one year

Study Details

Patients with neovascular Age-related macular degeneration (AMD) and the particular feature of pigment epithelial detachments (PEDs) were not studied in the Phase III trials for ranibizumab (Lucentis). The PrONTO study was the first ranibizumab study to enroll such patients but only treated with ranibizumab until fluid within the layers of the retina was absent, not until the entire PED was absent. This study hypothesizes that there may be a difference in benefit between patients treated until just the retinal edema is gone and those in which the retinal edema and PED are both gone.

Key Dates

First listed
Jan 11, 2008
Start date
Oct 31, 2006
Status verified
Apr 2012
Primary completion
Dec 31, 2009
Completion
Dec 31, 2009

Study Design

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

Arms

  • Active Comparator: Group1
    Will receive ranibizumab treatments until resolution of macular edema only and as macular edema recurs.
  • Active Comparator: Group 2
    Will receive ranibizumab treatments until resolution of both macular edema and PED, and as macular edema or PED recur.

Primary Outcome Measure

Mean change in visual acuity from baseline over 12 months [ Time Frame: 12 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
Pacific Eye AssociatesSan FranciscoCalifornia94115-

Find similar trials in San Francisco, CA

By condition
Age-related macular degeneration
By specialty
OphthalmologyRetina
By research site
Pacific Eye Associates· San Francisco, CA

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