Evaluation Of Safety And Efficacy Of 0.3 Mg/Eye Macugen In Patients With Small Age-Related Macular Degeneration Lesions - Full Text View

Sponsors and Collaborators:	Pfizer Monitoring : ITEC GROUP 3, avenue Georges Clemenceau 33150 Cenon Bordeaux France
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00324116

Purpose

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.

Condition	Intervention	Phase
Macular Degeneration	Procedure: Color fundus photography Procedure: Fluorescein angiography Drug: pegaptanib sodium (Macugen) Procedure: IOP Procedure: Indocyanine green angiography Procedure: Laboratory tests Procedure: NEI-VFQ 25 questionnaire Procedure: OCT Procedure: Visual acuity	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study
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

Resource links provided by NLM:

Genetics Home Reference related topics: X-linked juvenile retinoschisis

MedlinePlus related topics: Macular Degeneration

Drug Information available for: Pegaptanib sodium D&C Yellow no. 8 Fluorescein Indocyanine green

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:

Proportion of responders at 54 weeks, defined as patients having lost from baseline less than (<) 15 letters of the best-corrected visual acuity expressed as an ETDRS score ; this includes patients with visual acuity gain from baseline. [ Time Frame: after 54 weeks of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Changes from baseline in patient reported vision-related functioning and quality of life as measured using the NEI-VFQ 25 at 54 weeks. [ Time Frame: after 54 weeks of treatment ] [ Designated as safety issue: No ]
Proportion of patients with severe visual loss at 54 weeks (loss from baseline of more than 30 letters of visual acuity) [ Time Frame: after 54 weeks of treatment ] [ Designated as safety issue: No ]
Proportion of patients maintaining vision at 54 weeks (gain from baseline of more than 0 letters of visual acuity) [ Time Frame: after 54 weeks of treatment ] [ Designated as safety issue: No ]
Proportion of patients gaining vision at 54 weeks (gain from baseline of more than 15 letters of visual acuity) [ Time Frame: after 54 weeks of treatment ] [ Designated as safety issue: No ]
Mean change from baseline in visual acuity at 6, 12 and 54 weeks [ Time Frame: after 6, 12 and 54 weeks of treatment ] [ Designated as safety issue: No ]
Proportion of patients progressing to a visual acuity of < ou = 20/200 at 54 weeks of those who had a visual acuity of > 20/200 at baseline [ Time Frame: after 54 weeks of treatment ] [ Designated as safety issue: No ]

Enrollment:	79
Study Start Date:	July 2006
Study Completion Date:	August 2008
Primary Completion Date:	August 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Procedure Other intervention - no drug.	Procedure: Color fundus photography baseline, week 12, 30 and 54. Procedure: Fluorescein angiography baseline, week 12, 30 and 54. Procedure: IOP every 6 weeks before and after injection of macugen Procedure: Indocyanine green angiography baseline, week 12, 30 and 54. Procedure: Laboratory tests at baseline Procedure: NEI-VFQ 25 questionnaire baseline and week 54 Procedure: OCT baseline and every 6 weeks Procedure: Visual acuity every 6 weeks before injection of macugen
Active: Experimental	Drug: pegaptanib sodium (Macugen) 0.3 MG/EYE PEGAPTANIB SODIUM by INTRAVITREOUS INJECTION GIVEN EVERY 6 WEEKS FOR 54 WEEKS

Arms

Assigned Interventions

Procedure

Other intervention - no drug.

Procedure: Color fundus photography

baseline, week 12, 30 and 54.

Procedure: Fluorescein angiography

baseline, week 12, 30 and 54.

Procedure: IOP

every 6 weeks before and after injection of macugen

Procedure: Indocyanine green angiography

baseline, week 12, 30 and 54.

Procedure: Laboratory tests

at baseline

Procedure: NEI-VFQ 25 questionnaire

baseline and week 54

Procedure: OCT

baseline and every 6 weeks

Procedure: Visual acuity

every 6 weeks before injection of macugen

Active: Experimental

Drug: pegaptanib sodium (Macugen)

0.3 MG/EYE PEGAPTANIB SODIUM by INTRAVITREOUS INJECTION GIVEN EVERY 6 WEEKS FOR 54 WEEKS

Eligibility

Ages Eligible for Study:	50 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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)
Aged > or = 50 years
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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00324116

Locations

France
Pfizer Investigational Site
MULHOUSE Cedex 1, France, 68070
Pfizer Investigational Site
Bayonne, France, 64100
Pfizer Investigational Site
Bordeaux, France, 33076
Pfizer Investigational Site
Paris, France, 75015
Pfizer Investigational Site
Paris cedex 12, France, 75557
Pfizer Investigational Site
DIJON Cedex, France, 21033
Pfizer Investigational Site
PARIS Cedex 19, France, 75940
Pfizer Investigational Site
Strasbourg, France, 67000
Pfizer Investigational Site
Nancy, France, 54000
Pfizer Investigational Site
Paris, France, 75006
Pfizer Investigational Site
La Tronche, France, 38700
Pfizer Investigational Site
Bordeaux, France, 33100
Pfizer Investigational Site
La Rochefoucauld, France, 16110
Pfizer Investigational Site
Limoges Cedex 1, France, 87042
Pfizer Investigational Site
Toulouse, France, 31054
Pfizer Investigational Site
Brest, France, 29200
Pfizer Investigational Site
Strasbourg Cedex, France, 67091
Pfizer Investigational Site
Marseille, France, 13008
Pfizer Investigational Site
Montpellier, France, 34000
Pfizer Investigational Site
Montpellier, France, 34070
Pfizer Investigational Site
Nantes Cedex 1, France, 44093
Pfizer Investigational Site
Rives, France, 38140
Pfizer Investigational Site
Toulouse, France, 31200
Pfizer Investigational Site
Saint-Herblain, France, 44819
Pfizer Investigational Site
Rouen, France, 76000
Pfizer Investigational Site
Lyon, France, 69003
Pfizer Investigational Site
Belfort Cedex, France, 90016
Pfizer Investigational Site
Lille, France, 59800
France, Cedex
Pfizer Investigational Site
Creteil, Cedex, France, 94010
Pfizer Investigational Site
Besancon, Cedex, France, 25030
Pfizer Investigational Site
Poitiers, Cedex, France, 86021
Pfizer Investigational Site
Macon, Cedex, France, 71018
France, Cedex 09
Pfizer Investigational Site
Angers, Cedex 09, France, 49933
France, Cedex 4
Pfizer Investigational Site
Lyon, Cedex 4, France, 69317

Sponsors and Collaborators

Pfizer

Monitoring : ITEC GROUP 3, avenue Georges Clemenceau 33150 Cenon Bordeaux France

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Additional Information:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Pfizer Inc ( Director, Clinical Trial Disclosure Group )
Study ID Numbers:	A5751016
Study First Received:	May 8, 2006
Last Updated:	September 3, 2008
ClinicalTrials.gov Identifier:	NCT00324116 History of Changes
Health Authority:	France: Afssaps - French Health Products Safety Agency

Study placed in the following topic categories:

Eye Diseases
Retinal Degeneration
Macular Degeneration
Retinal Diseases

Additional relevant MeSH terms:

Eye Diseases
Retinal Degeneration
Macular Degeneration
Retinal Diseases

ClinicalTrials.gov processed this record on September 01, 2009