Safety And Tolerability Study Of RN6G In Patients With Dry, Age-Related Macular Degeneration

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Pfizer

Status and phase

Completed
Phase 1

Conditions

Macular Degeneration
Retinal Degeneration
Age-Related Maculopathy
Age-Related Maculopathies
Eye Diseases

Treatments

Biological: RN6G
Biological: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT00877032
B1181001

Details and patient eligibility

About

The purpose of this study is to determine the safety and tolerability of RN6G in patients with dry, age-related macular degeneration.

Enrollment

57 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Be of non-childbearing potential.
  • Diagnosis of dry AMD as defined by the Age-Related Eye Disease Study (AREDS, 2005), including uni- or multi-focal GA, without foveal involvement.
  • BCVA of 20/320 or better in the worst eye.

Exclusion criteria

  • Diagnosis of exudative (wet) AMD, with subretinal or choroidal neovascular lesions.
  • Diagnosis or history of Alzheimer's disease, dementia or neurodegenerative disorders.
  • Diagnosis or recent history of clinically significant cerebrovascular disease.
  • Uncontrolled hypertension.
  • Uncontrolled Type 1 or Type 2 diabetes mellitus.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Single Group Assignment

Masking

Quadruple Blind

57 participants in 1 patient group

Arm 1
Experimental group
Treatment:
Biological: Placebo
Biological: RN6G

Trial contacts and locations

19

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Data sourced from clinicaltrials.gov

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