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

Primary Purpose

Macular Degeneration

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
AdGVPEDF.11D
Sponsored by
GenVec
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Macular Degeneration focused on measuring Wet Age-Related Macular Degeneration, Age-Related Maculopathies

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Retina-Vitreous Associates Medical Group
  • Retinal Transplantation Laboratory
  • UCLA - Jules Stein Eye Research Center
  • Florida Eye Microsurgical Institute, Inc.
  • Johns Hopkins Hospital School of Medicine
  • Kresge Eye Institute
  • Casey Eye Institute
  • Baylor College of Medicine
  • University of Washington

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
April 28, 2005
Last Updated
May 11, 2011
Sponsor
GenVec
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1. Study Identification

Unique Protocol Identification Number
NCT00109499
Brief Title
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

2. Study Status

Record Verification Date
May 2011
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
GenVec

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Macular Degeneration
Keywords
Wet Age-Related Macular Degeneration, Age-Related Maculopathies

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Masking
None (Open Label)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
AdGVPEDF.11D

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Retina-Vitreous Associates Medical Group
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90211
Country
United States
Facility Name
Retinal Transplantation Laboratory
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033-4682
Country
United States
Facility Name
UCLA - Jules Stein Eye Research Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095-7000
Country
United States
Facility Name
Florida Eye Microsurgical Institute, Inc.
City
Boynton Beach
State/Province
Florida
ZIP/Postal Code
33426
Country
United States
Facility Name
Johns Hopkins Hospital School of Medicine
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Name
Kresge Eye Institute
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201-1423
Country
United States
Facility Name
Casey Eye Institute
City
Portland
State/Province
Oregon
ZIP/Postal Code
97201
Country
United States
Facility Name
Baylor College of Medicine
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
University of Washington
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195
Country
United States

12. IPD Sharing Statement

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

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