Phase 4
N=81
Evaluation Of Safety And Efficacy Of 0.3 Mg/Eye Macugen In Patients With Small Age-Related Macular Degeneration Lesions
Macular Degeneration
Bottom Line
View on ClinicalTrials.gov: NCT00324116 ↗Enrolled (actual)
81
Serious AEs
—
Results posted
Oct 2009
Primary outcome: Primary: Number of Responders for Visual Acuity Using Early Treatment Diabetic Retinopathy Study (ETDRS) — 40; 7; 33 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- pegaptanib sodium (Macugen) (Drug)
- Age
- Adult, Older Adult · 50+ yrs
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- Aug 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Responders for Visual Acuity Using Early Treatment Diabetic Retinopathy Study (ETDRS) |
40; 7; 33 | — |
| SECONDARY Change From Baseline in Visual Acuity |
-4.29; -5.86; -11.12 | — |
| SECONDARY Number of Subjects Gaining Vision |
4; 74; 2 | — |
| SECONDARY Number of Subjects Maintaining Vision |
18; 60; 2 | — |
| SECONDARY Number of Subjects With Severe Visual Loss |
11; 67; 2 | — |
| SECONDARY Number of Subjects With a Distance Visual Acuity of > 20/200 at Baseline and Progressing to (<= 20/200) |
20; 57 | — |
| SECONDARY Change in Vision-related Functioning and Quality of Life Using the National Eye Institute Visual Functioning Questionnaire-25 (NEI-VFQ 25). |
-2.25; -4.17; 3.90; 0.35; -3.88; -6.78 | — |
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
Data sourced from ClinicalTrials.gov (NCT00324116). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.