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

Macular Degeneration Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00324116
• Other study ID #: A5751016
• Status: Completed
• Phase: Phase 4
• First received: May 8, 2006
• Last updated: March 15, 2010
• Start date: July 2006
• Est. completion date: August 2008

Study information

• Verified date: March 2010
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 81
• Est. completion date: August 2008
• Est. primary completion date: August 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Macular Degeneration

Intervention

Drug:
• pegaptanib sodium (Macugen)
0.3 MG/eye pegaptanib IB sodium by intravitreous injection given every 6 weeks for 54 weeks.

Locations

Country	Name	City	State
France	Pfizer Investigational Site	Angers	Cedex 09
France	Pfizer Investigational Site	Bayonne
France	Pfizer Investigational Site	Belfort Cedex
France	Pfizer Investigational Site	Besancon	Cedex
France	Pfizer Investigational Site	Bordeaux
France	Pfizer Investigational Site	Bordeaux
France	Pfizer Investigational Site	Brest
France	Pfizer Investigational Site	Creteil	Cedex
France	Pfizer Investigational Site	DIJON Cedex
France	Pfizer Investigational Site	La Rochefoucauld
France	Pfizer Investigational Site	La Tronche
France	Pfizer Investigational Site	Lille
France	Pfizer Investigational Site	Limoges Cedex 1
France	Pfizer Investigational Site	Lyon
France	Pfizer Investigational Site	Lyon	Cedex 4
France	Pfizer Investigational Site	Macon	Cedex
France	Pfizer Investigational Site	Marseille
France	Pfizer Investigational Site	Montpellier
France	Pfizer Investigational Site	Montpellier
France	Pfizer Investigational Site	MULHOUSE Cedex 1
France	Pfizer Investigational Site	Nancy
France	Pfizer Investigational Site	Nantes Cedex 1
France	Pfizer Investigational Site	Paris
France	Pfizer Investigational Site	Paris
France	Pfizer Investigational Site	Paris cedex 12
France	Pfizer Investigational Site	PARIS Cedex 19
France	Pfizer Investigational Site	Poitiers	Cedex
France	Pfizer Investigational Site	Rives
France	Pfizer Investigational Site	Rouen
France	Pfizer Investigational Site	Saint-Herblain
France	Pfizer Investigational Site	Strasbourg
France	Pfizer Investigational Site	Strasbourg Cedex
France	Pfizer Investigational Site	Toulouse
France	Pfizer Investigational Site	Toulouse

Sponsors (2)

Lead Sponsor	Collaborator
Pfizer	ITEC GROUP 3

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Responders for Visual Acuity Using Early Treatment Diabetic Retinopathy Study (ETDRS)	Best-corrected visual acuity assessed using retroilluminated modified Ferris-Bailey ETDRS charts. When possible to measure visual acuity @ 2.0 m (=20 letters), visual acuity score for that eye recorded as number of letters correct plus 15; otherwise, score was number of letters read correctly @ 1.0 m plus number, if any, read @ 2.0 m. If no letter was read correctly either at 2.0 or 1.0 m, then visual acuity score was recorded as 0. Responders defined as subjects having lost from baseline less than 15 letters of the best-corrected visual acuity; includes subjects with visual acuity gain.	Baseline, 54 Weeks	No
Secondary	Change From Baseline in Visual Acuity	Best-corrected visual acuity assessed using retroilluminated modified Ferris-Bailey ETDRS charts. When possible to measure visual acuity @ 2.0 m (=20 letters), visual acuity score for that eye recorded as number of letters correct plus 15; otherwise, score was number of letters read correctly @ 1.0 m plus number, if any, read @ 2.0 m. If no letter was read correctly either at 2.0 or 1.0 m, then visual acuity score was recorded as 0. Change: mean score at observation minus mean score at baseline.	Baseline, 6 weeks, 12 weeks, 54 weeks	No
Secondary	Number of Subjects Gaining Vision	Subjects gaining vision: gain from baseline of more than 15 letters of visual acuity. Best-corrected visual acuity assessed using retroilluminated modified Ferris-Bailey ETDRS charts. When possible to measure visual acuity @ 2.0 m (=20 letters), visual acuity score for that eye recorded as number of letters correct plus 15; otherwise, score was number of letters read correctly @ 1.0 m plus number, if any, read @ 2.0 m. If no letter was read correctly either at 2.0 or 1.0 m, then visual acuity score was recorded as 0.	54 weeks or at early termination	No
Secondary	Number of Subjects Maintaining Vision	Subjects maintaining vision: gain from baseline of more than 0 letters of visual acuity. Best-corrected visual acuity assessed using retroilluminated modified Ferris-Bailey ETDRS charts. When possible to measure visual acuity @ 2.0 m (=20 letters), visual acuity score for that eye recorded as number of letters correct plus 15; otherwise, score was number of letters read correctly @ 1.0 m plus number, if any, read @ 2.0 m. If no letter was read correctly either at 2.0 or 1.0 m, then visual acuity score was recorded as 0.	54 weeks or at early termination	No
Secondary	Number of Subjects With Severe Visual Loss	Subjects with severe visual loss: loss from baseline of >= 30 letters of visual acuity. Best-corrected visual acuity assessed using retroilluminated modified Ferris-Bailey ETDRS charts. When possible to measure visual acuity @ 2.0 m (=20 letters), visual acuity score for that eye recorded as number of letters correct plus 15; otherwise, score was number of letters read correctly @ 1.0 m plus number, if any, read @ 2.0 m. If no letter was read correctly either at 2.0 or 1.0 m, then visual acuity score was recorded as 0.	54 weeks or at early termination	No
Secondary	Number of Subjects With a Distance Visual Acuity of > 20/200 at Baseline and Progressing to (<= 20/200)	Subjects with improving scores are those with > 20/200 at Baseline and progressing to =< 20/200 at Week 54.; Subjects with no change are those with > 20/200 at Baseline and remaining at > 20/200 at Week 54.	54 weeks	No
Secondary	Change in Vision-related Functioning and Quality of Life Using the National Eye Institute Visual Functioning Questionnaire-25 (NEI-VFQ 25).	Patient reported vision-related functioning and quality of life as measured using the 25 item NEI-VFQ 25. Change = Mean score at 54 weeks - mean score at baseline. A positive change represents an increase in function/health from Baseline. Items grouped as the following - Composite: mean score items 1-25; General Health: item 1; General Vision: item 2; Ocular Pain:4,19; Near Vision:5,6,7; Distance Vision:8,9,14; Social Functioning:11,13; Mental Health Activities:3,21,22,25; Role Difficulties:17,18; Dependency:20,23,24; Driving:15c,16, 16a; Color Vision: 12; Peripheral Vision: 10.	Baseline, 54 weeks or at early termination	No

External Links

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