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

This study has been completed.
Sponsor:
Collaborator:
ITEC GROUP 3
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00324116
First received: May 8, 2006
Last updated: March 15, 2010
Last verified: March 2010

May 8, 2006
March 15, 2010
July 2006
August 2008   (final data collection date for primary outcome measure)
Number of Responders for Visual Acuity Using Early Treatment Diabetic Retinopathy Study (ETDRS) [ Time Frame: Baseline, 54 Weeks ] [ Designated as safety issue: No ]
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 less than (<) 15 letters of the best-corrected visual acuity expressed
  • Proportion of responders at 54 weeks, defined as patients having lost from
  • as an ETDRS score; this includes patients with visual acuity gain from baseline.
Complete list of historical versions of study NCT00324116 on ClinicalTrials.gov Archive Site
  • Change From Baseline in Visual Acuity [ Time Frame: Baseline, 6 weeks, 12 weeks, 54 weeks ] [ Designated as safety issue: No ]
    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.
  • Number of Subjects Gaining Vision [ Time Frame: 54 weeks or at early termination ] [ Designated as safety issue: No ]
    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.
  • Number of Subjects Maintaining Vision [ Time Frame: 54 weeks or at early termination ] [ Designated as safety issue: No ]
    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.
  • Number of Subjects With Severe Visual Loss [ Time Frame: 54 weeks or at early termination ] [ Designated as safety issue: No ]
    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.
  • Number of Subjects With a Distance Visual Acuity of > 20/200 at Baseline and Progressing to (<= 20/200) [ Time Frame: 54 weeks ] [ Designated as safety issue: No ]

    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.

  • Change in Vision-related Functioning and Quality of Life Using the National Eye Institute Visual Functioning Questionnaire-25 (NEI-VFQ 25). [ Time Frame: Baseline, 54 weeks or at early termination ] [ Designated as safety issue: No ]
    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.
  • 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 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
  • Changes from baseline in patient reported vision-related functioning
  • and quality of life as measured using the NEI-VFQ 25 at 54 weeks.
Not Provided
Not Provided
 
Evaluation Of Safety And Efficacy Of 0.3 Mg/Eye Macugen In Patients With Small Age-Related Macular Degeneration Lesions
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

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.

Not Provided
Interventional
Phase 4
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Macular Degeneration
Drug: pegaptanib sodium (Macugen)
0.3 MG/eye pegaptanib IB sodium by intravitreous injection given every 6 weeks for 54 weeks.
Other Name: MACUGEN
Experimental: Active
Intervention: Drug: pegaptanib sodium (Macugen)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
81
August 2008
August 2008   (final data collection date for primary outcome measure)

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
Both
50 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00324116
A5751016
No
Director, Clinical Trial Disclosure Group, Pfizer Inc
Pfizer
ITEC GROUP 3
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
March 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP