NCT00109499

Brief Summary

The primary purpose of this study is to assess the safety of AdGVPEDF.11D when given to patients with "wet" age-related macular degeneration (AMD). AdGVPEDF.11D is a replication deficient (E1, E3 and E4 deleted) adenovirus vector containing the gene for the PEDF (pigment epithelium-derived factor) protein. PEDF is a protein that naturally exists in the human eye, but whose levels are altered in diseases characterized by ocular neovascularization like AMD. The PEDF protein is known to have anti-angiogenic effects or, in other words, it has the ability to inhibit growth of new blood vessels. AdGVPEDF.11D will be delivered once via intravitreal injection into one eye. The injected eye will be the eye with the worst visual acuity.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

9 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 28, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 29, 2005

Completed
Last Updated

May 12, 2011

Status Verified

May 1, 2011

First QC Date

April 28, 2005

Last Update Submit

May 11, 2011

Conditions

Macular Degeneration

Keywords

Wet Age-Related Macular DegenerationAge-Related Maculopathies

Interventions

AdGVPEDF.11DDRUG

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age greater than or equal to 50 years;
  • Severe neovascular AMD in at least one eye responsible for a best corrected vision of 20/200 or worse in the study eye (if both eyes have neovascular AMD and equal visual acuity scores, the study eye will be determined by the investigator);
  • Best corrected visual acuity in the fellow eye must be equal to or better than the study eye;
  • Fluorescein angiography of the study eye must show evidence of a leaking subfoveal choroidal neovascular lesion. The subfoveal component must consist of CNV (choroidal neovascularization), blood or fibrosis. The total size of the lesion must be ≤12 MPS disc areas. The presence of a leaking subfoveal choroidal neovascular lesion will be evaluated by the investigator at the clinical site to determine patients' eligibility.
  • Must not be candidates for (including patients who have had treatment with either modality in the past and are no longer candidates) or must have refused treatment with subfoveal laser photocoagulation or PDT (photodynamic therapy);
  • Informed consent;
  • Able to comply with protocol requirements including follow-up visits.

You may not qualify if:

  • Liver enzymes \> 2 x ULN (ALT, AST, bilirubin);
  • Clinical evidence of active infection of any type, including adenovirus, hepatitis A, B, or C virus or HIV virus;
  • Other treatment for AMD in the study eye within the last twelve weeks prior to Day 1;
  • Other experimental medications within the last four weeks prior to Day 1;
  • Significant retinal disease other than neovascular AMD, such as diabetic retinopathy or retinal vascular occlusion;
  • Significant non-retinal disease such as ocular atrophy;
  • Cataract or other significant media opacity that might compromise examination and photography of the posterior segment;
  • Other causes of choroidal neovascularization such as pathologic myopia ( \> 8 diopters), ocular histoplasmosis or angioid streaks;
  • Evidence of inflammation (grade 1 or higher) in the anterior and/or posterior chambers;
  • Cataract surgery or submacular surgery within 3 months;
  • Prior ocular treatment with radiation;
  • Known allergy to fluorescein;
  • Abnormal prothrombin or partial thromboplastin time ( \> 1.5 X ULN) or anticoagulant therapy that cannot be withheld for treatment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Retina-Vitreous Associates Medical Group

Beverly Hills, California, 90211, United States

Location

Retinal Transplantation Laboratory

Los Angeles, California, 90033-4682, United States

Location

UCLA - Jules Stein Eye Research Center

Los Angeles, California, 90095-7000, United States

Location

Florida Eye Microsurgical Institute, Inc.

Boynton Beach, Florida, 33426, United States

Location

Johns Hopkins Hospital School of Medicine

Baltimore, Maryland, 21287, United States

Location

Kresge Eye Institute

Detroit, Michigan, 48201-1423, United States

Location

Casey Eye Institute

Portland, Oregon, 97201, United States

Location

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

University of Washington

Seattle, Washington, 98195, United States

Location

MeSH Terms

Conditions

Macular Degeneration

Condition Hierarchy (Ancestors)

Retinal DegenerationRetinal DiseasesEye Diseases

Study Design

Study Type
interventional
Phase
phase 1
Masking
NONE
Purpose
TREATMENT
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

April 28, 2005

First Posted

April 29, 2005

Last Updated

May 12, 2011

Record last verified: 2011-05

Locations

US(9)