Status:
COMPLETED
Evaluation Of Safety And Efficacy Of 0.3 Mg/Eye Macugen In Patients With Small Age-Related Macular Degeneration Lesions
Lead Sponsor:
Pfizer
Collaborating Sponsors:
ITEC GROUP 3
Conditions:
Macular Degeneration
Eligibility:
All Genders
50+ years
Phase:
PHASE4
Brief Summary
To evaluate the efficacy, based on the best-corrected visual acuity (using the ETDRS chart), of a 0.3 mg/eye pegaptanib sodium intravitreous injection given every 6 weeks for 54 weeks in patients with...
Eligibility Criteria
Inclusion
- Clinical and angiographic evidence of juxtafoveal or subfoveal choroidal neovascularization secondary to AMD with a total lesion size of less than 2 MPS disc areas
- Best-corrected visual acuity in the study eye greater than 54 letters (ETDRS)
- Women must be using 2 forms of effective contraception
- Adequate hematological, renal and liver functions
Exclusion
- Any atrophy or fibrosis; any retinal hemorrhage measuring more than 1 disc area
- Any extrafoveal choroidal neovascularization
- Any intraocular surgery or thermal laser to the study eye within 3 months of enrollment
- Previous or concomitant therapy for AMD including PDT with verteporfin (Visudyne) or subfoveal/non-foveal thermal laser therapy, transpupillary thermotherapy, external beam radiation, submacular surgery.
- Presence of other causes of choroidal neovascularization, including pathological myopia, the ocular histoplasmosis syndrome, angioid streaks, choroidal rupture and multifocal choroiditis
Key Trial Info
Start Date :
July 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2008
Estimated Enrollment :
81 Patients enrolled
Trial Details
Trial ID
NCT00324116
Start Date
July 1 2006
End Date
August 1 2008
Last Update
March 23 2010
Active Locations (34)
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1
Pfizer Investigational Site
Angers, Cedex 09, France, 49933
2
Pfizer Investigational Site
Lyon, Cedex 4, France, 69317
3
Pfizer Investigational Site
Besançon, Cedex, France, 25030
4
Pfizer Investigational Site
Créteil, Cedex, France, 94010