Clinical trial NCT00109499: Study of AdGVPEDF.11D in Neovascular Age-related Macular Degeneration (AMD)
Official title: An Open-label, Phase I, Single Administration, Dose- Escalation Study of AdGVPEDF.11D in Neovascular Age-related Macular Degeneration (AMD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Macular Degeneration
Keywords: Wet Age-Related Macular Degeneration
Age-Related Maculopathies
Lead sponsor: GenVec
Sponsor class: INDUSTRY
First posted: 2005-04-29
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Beverly Hills
country: United States
facility: Retina-Vitreous Associates Medical Group
state: California
city: Los Angeles
country: United States
facility: Retinal Transplantation Laboratory
state: California
city: Los Angeles
country: United States
facility: UCLA - Jules Stein Eye Research Center
state: California
city: Boynton Beach
country: United States
facility: Florida Eye Microsurgical Institute, Inc.
state: Florida
city: Baltimore
country: United States
facility: Johns Hopkins Hospital School of Medicine
state: Maryland
city: Detroit
country: United States
facility: Kresge Eye Institute
state: Michigan
city: Portland
country: United States
facility: Casey Eye Institute
state: Oregon
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
city: Seattle
country: United States
facility: University of Washington
state: Washington
Study officials:
References: