Evaluation Of Safety And Efficacy Of 0.3 Mg/Eye Macugen In Patients With Small Age-Related Macular Degeneration Lesions
NCT00324116
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- 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
- 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
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| Descriptive Information | ||||
|---|---|---|---|---|
| Brief Title ICMJE | Evaluation Of Safety And Efficacy Of 0.3 Mg/Eye Macugen In Patients With Small Age-Related Macular Degeneration Lesions | |||
| Official Title ICMJE | 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 | |||
| Brief 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. | |||
| Detailed Description | Not Provided | |||
| Study Type ICMJE | Interventional | |||
| Study Phase ICMJE | Phase 4 | |||
| Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment | |||
| Condition ICMJE | Macular Degeneration | |||
| Intervention ICMJE | Drug: pegaptanib sodium (Macugen)
0.3 MG/eye pegaptanib IB sodium by intravitreous injection given every 6 weeks for 54 weeks. Other Name: MACUGEN | |||
| Study Arms ICMJE | Experimental: Active
Intervention: Drug: pegaptanib sodium (Macugen) | |||
| Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
| Recruitment Information | ||||
| Recruitment Status ICMJE | Completed | |||
| Actual Enrollment ICMJE | 81 | |||
| Original Enrollment ICMJE | 195 | |||
| Actual Study Completion Date ICMJE | August 2008 | |||
| Actual Primary Completion Date | August 2008 (Final data collection date for primary outcome measure) | |||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| |||
| Sex/Gender ICMJE |
| |||
| Ages ICMJE | 50 Years and older (Adult, Older Adult) | |||
| Accepts Healthy Volunteers ICMJE | No | |||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
| Listed Location Countries ICMJE | France | |||
| Removed Location Countries | ||||
| Administrative Information | ||||
| NCT Number ICMJE | NCT00324116 | |||
| Other Study ID Numbers ICMJE | A5751016 | |||
| Has Data Monitoring Committee | No | |||
| U.S. FDA-regulated Product | Not Provided | |||
| IPD Sharing Statement ICMJE | Not Provided | |||
| Responsible Party | Director, Clinical Trial Disclosure Group, Pfizer Inc | |||
| Study Sponsor ICMJE | Pfizer | |||
| Collaborators ICMJE | ITEC GROUP 3 | |||
| Investigators ICMJE |
| |||
| PRS Account | Pfizer | |||
| Verification Date | March 2010 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP | ||||