Clinical trial NCT00324116: Evaluation Of Safety And Efficacy Of 0.3 Mg/Eye Macugen In Patients With Small Age-Related Macular Degeneration Lesions
Official title: A Prospective, Open-Label Multi Center Trial Evaluating The Safety And Efficacy Of 0.3 Mg/Eye Pegaptanib Sodium (Macugen) Intravitreous Injection Given Every 6 Weeks For 54 Weeks In Patients With Small Neovascular Age-Related Macular Degeneration (AMD) Lesions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Macular Degeneration
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
Collaborators: name: ITEC GROUP 3
First posted: 2006-05-10
Enrollment: 81
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 exudative age-related macular degeneration and evidence of recent onset, subfoveal and/or juxtafoveal choroidal neovascularization.


Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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

Primary outcomes:
measure: Number of Responders for Visual Acuity Using Early Treatment Diabetic Retinopathy Study (ETDRS)
timeFrame: Baseline, 54 Weeks
Secondary outcomes:
measure: Change From Baseline in Visual Acuity
timeFrame: Baseline, 6 weeks, 12 weeks, 54 weeks
measure: Number of Subjects Gaining Vision
timeFrame: 54 weeks or at early termination
measure: Number of Subjects Maintaining Vision
timeFrame: 54 weeks or at early termination
measure: Number of Subjects With Severe Visual Loss
timeFrame: 54 weeks or at early termination
measure: Number of Subjects With a Distance Visual Acuity of > 20/200 at Baseline and Progressing to (<= 20/200)
timeFrame: 54 weeks
measure: Change in Vision-related Functioning and Quality of Life Using the National Eye Institute Visual Functioning Questionnaire-25 (NEI-VFQ 25).
timeFrame: Baseline, 54 weeks or at early termination
Other outcomes:
Locations:
city: Angers
country: France
facility: Pfizer Investigational Site
state: Cedex 09
city: Lyon
country: France
facility: Pfizer Investigational Site
state: Cedex 4
city: Besancon
country: France
facility: Pfizer Investigational Site
state: Cedex
city: Creteil
country: France
facility: Pfizer Investigational Site
state: Cedex
city: Macon
country: France
facility: Pfizer Investigational Site
state: Cedex
city: Poitiers
country: France
facility: Pfizer Investigational Site
state: Cedex
city: Bayonne
country: France
facility: Pfizer Investigational Site
city: Belfort Cedex
country: France
facility: Pfizer Investigational Site
city: Bordeaux
country: France
facility: Pfizer Investigational Site
city: Bordeaux
country: France
facility: Pfizer Investigational Site
city: Brest
country: France
facility: Pfizer Investigational Site
city: DIJON Cedex
country: France
facility: Pfizer Investigational Site
city: La Rochefoucauld
country: France
facility: Pfizer Investigational Site
city: La Tronche
country: France
facility: Pfizer Investigational Site
city: Lille
country: France
facility: Pfizer Investigational Site
city: Limoges Cedex 1
country: France
facility: Pfizer Investigational Site
city: Lyon
country: France
facility: Pfizer Investigational Site
city: Marseille
country: France
facility: Pfizer Investigational Site
city: Montpellier
country: France
facility: Pfizer Investigational Site
city: Montpellier
country: France
facility: Pfizer Investigational Site
city: MULHOUSE Cedex 1
country: France
facility: Pfizer Investigational Site
city: Nancy
country: France
facility: Pfizer Investigational Site
city: Nantes Cedex 1
country: France
facility: Pfizer Investigational Site
city: Paris cedex 12
country: France
facility: Pfizer Investigational Site
city: PARIS Cedex 19
country: France
facility: Pfizer Investigational Site
city: Paris
country: France
facility: Pfizer Investigational Site
city: Paris
country: France
facility: Pfizer Investigational Site
city: Rives
country: France
facility: Pfizer Investigational Site
city: Rouen
country: France
facility: Pfizer Investigational Site
city: Saint-Herblain
country: France
facility: Pfizer Investigational Site
city: Strasbourg Cedex
country: France
facility: Pfizer Investigational Site
city: Strasbourg
country: France
facility: Pfizer Investigational Site
city: Toulouse
country: France
facility: Pfizer Investigational Site
city: Toulouse
country: France
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: