Lucentis for Age-related Macular Degeneration Pigment Epithelial Detachments
Information source: Pacific Eye Associates
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Age-related Macular Degeneration; Pigment Epithelial Detachment; Neovascular Macular Degeneration; Wet Macular Degeneration
Intervention: ranibizumab (Drug)
Phase: Phase 2/Phase 3
Status: Completed
Sponsored by: Pacific Eye Associates Official(s) and/or principal investigator(s): Anne Fung, MD, Principal Investigator, Affiliation: Pacific Eye Associates / California Pacific Medical Center
Summary
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.
Clinical Details
Official title: Determining Optimal Treatment Algorithms for Macular Degeneration Pigment Epithelial Detachments Treated With Intraocular Lucentis
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Mean change in visual acuity from baseline over 12 months
Secondary outcome: Time to OCT resolution of macular edema and pigment epithelial detachmentProportion of patients with complete resolution of PED at 6 and 12 months Durability of outcome: time from last ranibizumab injection to retreatment
Eligibility
Minimum age: 50 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Neovascular age-related macular degeneration patients over age 50
- Presence of a pigment epithelial detachment on optical coherence tomography
- Initial or recurrent disease
- Previous treatment allowed
- Visual acuity between Snellen 20/40 - 20/400
Exclusion Criteria:
- More than three previous treatments with PDT or other radiation/laser therapy
- Previous vitrectomy or other AMD surgical intervention
- Severe scarring or severe concurrent ocular disease (uncontrolled glaucoma)
Patients eligible for the study are randomized into one of two groups. Group 1 receives
injections of ranibizumab until retinal edema is resolved. Group 2 receives ranibizumab
injections until both retinal edema and the PED are resolved. Study duration is one year
with visits once per month.
Locations and Contacts
Pacific Eye Associates, San Francisco, California 94115, United States
Additional Information
Pacific Eye Associates website
Related publications: Fung AE, Lalwani GA, Rosenfeld PJ, Dubovy SR, Michels S, Feuer WJ, Puliafito CA, Davis JL, Flynn HW Jr, Esquiabro M. An optical coherence tomography-guided, variable dosing regimen with intravitreal ranibizumab (Lucentis) for neovascular age-related macular degeneration. Am J Ophthalmol. 2007 Apr;143(4):566-83.
Starting date: October 2006
Last updated: April 10, 2012
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