Macular DegenerationPhase 1NCT00109499
Study of AdGVPEDF.11D in Neovascular Age-related Macular Degeneration (AMD)
A Phase 1 study testing AdGVPEDF.11D in people with Macular Degeneration, run by GenVec at 9 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Macular Degeneration
- What is being tested?
- AdGVPEDF.11D
- How many people
- Not given
- Where
- 9 sitesUnited States
- Study dates
- Start not givento not given
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
Johns Hopkins Hospital School of Medicine
Baltimore, Maryland, 21287
Retina-Vitreous Associates Medical Group
Beverly Hills, California, 90211
Florida Eye Microsurgical Institute, Inc.
Boynton Beach, Florida, 33426
Kresge Eye Institute
Detroit, Michigan, 48201-1423
Baylor College of Medicine
Houston, Texas, 77030
Retinal Transplantation Laboratory
Los Angeles, California, 90033-4682
UCLA - Jules Stein Eye Research Center
Los Angeles, California, 90095-7000
Casey Eye Institute
Portland, Oregon, 97201
University of Washington
Seattle, Washington, 98195
About this study
Official title: An Open-label, Phase I, Single Administration, Dose- Escalation Study of AdGVPEDF.11D in Neovascular Age-related Macular Degeneration (AMD)
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.
- Conditions
- Macular Degeneration
- Being tested
- AdGVPEDF.11D
- Keywords
- Wet Age-Related Macular Degeneration, Age-Related Maculopathies
- Medical subject headings
- Macular Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AdGVPEDF.11DDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2005 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Macular DegenerationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Masking
- None (open label)
Sponsor and investigators
- Lead sponsor
- GenVec
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00109499
- Sponsor's protocol ID
- GV-003.001
- Status last verified
- May 2011
- First submitted
- 28 Apr 2005
- Last updated
- 12 May 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Phase I, Single Administration, Dose- Escalation Study of AdGVPEDF.11D in Neovascular Age-related Macular Degeneration (AMD)
- ClinicalTrials.gov ID
- NCT00109499
- Acronym / sponsor ID
- GV-003.001
- Conditions
- Macular Degeneration
- Keywords
- Wet Age-Related Macular Degeneration, Age-Related Maculopathies
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- GenVecIndustry (pharma, biotech, devices)
- First posted
- 29 Apr 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Masking
- None (open label)
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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);
Key exclusion criteria (13 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AdGVPEDF.11D | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing AdGVPEDF.11D in people with Macular Degeneration, run by GenVec at 9 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 May 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2011.