An Open Label Trial to Investigate Macugen for the Preservation of Visual Function in Subjects With Neovascular AMD (PERSPECTIVES)

Pfizer

Status and phase: Terminated; Phase 4

Conditions: Macular Degeneration; Age Related Macular Degeneration (AMD); Choroidal Neovascularization (CNV)

Treatments: Drug: Pegaptanib Sodium 0.3 mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT00327470

A5751017

Details and patient eligibility

About

The purpose of this study is to determine the benefits of treating subjects with neovascular age-related macular degeneration (AMD) at an earlier stage of choroidal neovascularization (CNV) as compared to those with established CNV. Additionally, the study would like to determine the efficacy of Macugen in preserving visual function in those subjects having CNV secondary to neovascular AMD.

Full description

A decision was made by the sponsor (08 May 2009) to terminate this study early; the study had achieved the primary objective prior to termination. This study was not terminated due to safety reasons.

Enrollment: 288 patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Evidence of neovascular AMD in at least one eye. In subjects with bilateral neovascular AMD, only one eye would be eligible for enrollment
• Baseline visual acuity of greater than or equal to 20/320, or better than 25 ETDRS letters in the study eye

Exclusion criteria

• Previous treatment for CNV secondary to AMD, including any prior PDT with verteporfin, thermal laser photocoagulation, external beam radiation or transpupillary thermotherapy to the study eye
• Subjects having subfoveal fibrosis/ scar or atrophy representing > 25% of the total lesion size

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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288 participants in 1 patient group

Open Label

Experimental group

Treatment:

Drug: Pegaptanib Sodium 0.3 mg