| May 8, 2006 |
| November 10, 2009 |
| 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 ] |
- 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 ]
- Number of Subjects Gaining Vision [ Time Frame: 54 weeks or at early termination ] [ Designated as safety issue: No ]
- Number of Subjects Maintaining Vision [ Time Frame: 54 weeks or at early termination ] [ Designated as safety issue: No ]
- Number of Subjects With Severe Visual Loss [ Time Frame: 54 weeks or at early termination ] [ Designated as safety issue: No ]
- 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 ]
- 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 ]
|
- 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.
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| |
| 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. |
| |
| Phase IV |
| Interventional |
| Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study |
| Macular Degeneration |
| Drug: pegaptanib sodium (Macugen) |
| |
| |
| |
| 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 |
| Director, Clinical Trial Disclosure Group, Pfizer Inc |
| A5751016 |
| Pfizer |
| ITEC GROUP 3 |
| Study Director: |
Pfizer CT.gov Call Center |
Pfizer |
|
|
| Pfizer |
| November 2009 |