Clinical trial NCT00590694: Lucentis for Age-related Macular Degeneration Pigment Epithelial Detachments
Official title: Determining Optimal Treatment Algorithms for Macular Degeneration Pigment Epithelial Detachments Treated With Intraocular Lucentis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Age-related Macular Degeneration
Pigment Epithelial Detachment
Neovascular Macular Degeneration
Wet Macular Degeneration
Keywords: ranibizumab
Lucentis
Pigment Epithelial Detachment
Macular Degeneration
PrONTO
Lead sponsor: Pacific Eye Associates
Sponsor class: OTHER
Collaborators: name: Genentech, Inc.
First posted: 2008-01-11
Enrollment: 15
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility 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.

Primary outcomes:
measure: Mean change in visual acuity from baseline over 12 months
timeFrame: 12 months
Secondary outcomes:
measure: Time to OCT resolution of macular edema and pigment epithelial detachment
timeFrame: One year
measure: Proportion of patients with complete resolution of PED at 6 and 12 months
timeFrame: 12 months
measure: Durability of outcome: time from last ranibizumab injection to retreatment
timeFrame: One year
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: Pacific Eye Associates
state: California
Study officials:
affiliation: Pacific Eye Associates / California Pacific Medical Center
name: Anne Fung, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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. doi: 10.1016/j.ajo.2007.01.028.