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

Condition(s) targeted: Macular Degeneration

Intervention: pegaptanib sodium (Macugen) (Drug)

Phase: Phase 4

Status: Active, not recruiting

Sponsored by: Pfizer

Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer

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.

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 design: Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study

Primary outcome: 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.

Secondary outcome:

Changes from baseline in patient reported vision-related functioning and quality of life as measured using the NEI-VFQ 25 at 54 weeks.

Proportion of patients with severe visual loss at 54 weeks (loss from baseline of more than 30 letters of visual acuity)

Proportion of patients maintaining vision at 54 weeks (gain from baseline of more than 0 letters of visual acuity)

Proportion of patients gaining vision at 54 weeks (gain from baseline of more than 15 letters of visual acuity)

Mean change from baseline in visual acuity at 6, 12 and 54 weeks

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

Minimum age: 50 Years. Maximum age: N/A. Gender(s): Both.

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

Pfizer Investigational Site, MULHOUSE Cedex 1 68070, France

Pfizer Investigational Site, Bayonne 64100, France

Pfizer Investigational Site, Bordeaux 33076, France

Pfizer Investigational Site, Paris 75015, France

Pfizer Investigational Site, Paris cedex 12 75557, France

Pfizer Investigational Site, DIJON Cedex 21033, France

Pfizer Investigational Site, PARIS Cedex 19 75940, France

Pfizer Investigational Site, Strasbourg 67000, France

Pfizer Investigational Site, Strasbourg 67000, France

Pfizer Investigational Site, Strasbourg Cedex 67091, France

Pfizer Investigational Site, Paris 75006, France

Pfizer Investigational Site, La Tronche 38700, France

Pfizer Investigational Site, Bordeaux 33100, France

Pfizer Investigational Site, La Rochefoucauld 16110, France

Pfizer Investigational Site, Limoges Cedex 1 87042, France

Pfizer Investigational Site, Toulouse 31054, France

Pfizer Investigational Site, Brest 29200, France

Pfizer Investigational Site, Brest 29200, France

Pfizer Investigational Site, Nancy 54000, France

Pfizer Investigational Site, Marseille 13008, France

Pfizer Investigational Site, Montpellier 34000, France

Pfizer Investigational Site, Montpellier 34070, France

Pfizer Investigational Site, Nantes Cedex 1 44093, France

Pfizer Investigational Site, Rives 38140, France

Pfizer Investigational Site, Lyon 69003, France

Pfizer Investigational Site, Saint-Herblain 44819, France

Pfizer Investigational Site, Rouen 76000, France

Pfizer Investigational Site, Belfort Cedex 90016, France

Pfizer Investigational Site, Lille 59800, France

Pfizer Investigational Site, Creteil, Cedex 94010, France

Pfizer Investigational Site, Besancon, Cedex 25030, France

Pfizer Investigational Site, Poitiers, Cedex 86021, France

Pfizer Investigational Site, Macon, Cedex 71018, France

Pfizer Investigational Site, Angers, Cedex 09 49933, France

Pfizer Investigational Site, Lyon, Cedex 4 69317, France

To obtain contact information for a study center near you, click here.

Starting date: July 2006
Ending date: July 2008
Last updated: June 10, 2008