Study of AdGVPEDF.11D in Neovascular Age-related Macular Degeneration (AMD)

Status:

COMPLETED

Study of AdGVPEDF.11D in Neovascular Age-related Macular Degeneration (AMD)

Lead Sponsor:

GenVec

Conditions:

Macular Degeneration

Eligibility:

All Genders

50+ years

Phase:

PHASE1

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 ...

Eligibility Criteria

Inclusion

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.

Exclusion

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.

Key Trial Info

Start Date :

Trial Type :

INTERVENTIONAL

End Date :

Estimated Enrollment :

Patients enrolled

Trial Details

Trial ID

NCT00109499

Last Update

May 12 2011

Active Locations (9)

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Page 1 of 3 (9 locations)

Retina-Vitreous Associates Medical Group

Beverly Hills, California, United States, 90211

Retinal Transplantation Laboratory

Los Angeles, California, United States, 90033-4682

UCLA - Jules Stein Eye Research Center

Los Angeles, California, United States, 90095-7000