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Phase II/III Study of Anti-VEGF in Neovascular AMD

E

Eyetech Pharmaceuticals

Status and phase

Completed
Phase 3
Phase 2

Conditions

Choroidal Neovascularization
Macular Degeneration

Treatments

Drug: EYE001 anti-VEGF aptamer

Study type

Interventional

Funder types

Industry

Identifiers

NCT00021736
EOP1004B

Details and patient eligibility

About

The purpose of the study is to determine whether the anti-VEGF drug is effective at stabilizing and/or improving vision in patients with the wet form of AMD

Full description

This will be a randomized, double-masked, controlled, dose-ranging, multi-center comparative trial, in parallel groups. Patients will be stratified by clinical center, by percentage of classic CNV vessels: [predominantly classic (>50%) vs. minimally classic (1-49%) vs. purely occult (0%)], and according to whether, or not, they have received prior PDT with Visudyne (no more than once). All patients will be re-randomized after 54 weeks of treatment to either, continue or discontinue therapy for further 48 weeks.

Sex

All

Ages

50+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Patients of either gender, aged 50 years or above, diagnosed with subfoveal CNV secondary to AMD and with best corrected visual acuity of 20/40 to 20/320 in the absence of subfoveal atrophy or scarring in the study eye, and better or equal to 20/800 in the fellow eye, may be enrolled. Clinically significant concomitant diseases will be excluded.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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