Macular Degeneration Clinical Trial
Official title:
A Phase 1, Open-Label, Multi-Center, Dose-Escalating, Safety and Tolerability Study of a Single Intravitreal Injection of AAV2-sFLT01 in Patients With Neovascular Age-Related Macular Degeneration
This Phase 1 clinical research study will examine the safety and tolerability of an experimental gene transfer agent, AAV2-sFLT01, in patients with Neovascular Age-Related Macular Degeneration (AMD).
A new treatment for neovascular age-related macular degeneration (AMD) is being investigated.
Neovascular AMD is sometimes referred to as the "wet" form of AMD. The purpose of this Phase
1 clinical research study is to examine the safety and ability of an experimental study drug
to treat a complication of the disease which leads to vision loss. The name of the study drug
is "AAV2-sFLT01." This experimental study drug uses a virus to transfer a gene (genetic code)
into cells within the eye. The gene codes for a protein that is intended to diminish the
growth of abnormal blood vessels under the retina. The duration of the gene's effect is
currently unknown, but might last for years.
This clinical research study will look at the safety of a single administration of
AAV2-sFLT01 injected directly into the eye. There are 2 parts to this study, but patients
will take part in only one of them. In the first part of the study, 4 different doses of the
study drug will be studied in 4 separate groups of patients. Patients in the first part of
the study will not be randomized. In the second part of the study, the highest dose that was
safe and well tolerated will be studied in 10 more patients. Patients in this part of the
study may have a ranibizumab (Lucentis®) injection 26 weeks after their AAV2-sFLT01 injection
to verify their responsiveness to anti-VEGF therapy, if they have not demonstrated a response
to AAV2-sFLT01. The initial two parts of this protocol are expected to be completed in July,
2013.
All patients injected with AAV2-sFLT01 will be asked to participate in an Extended Follow-Up
(EFU) program for up to an additional 4 years. Participation is voluntary but strongly
encouraged as it allows for the long term collection of safety information as well as
information about the potential long term effects of the study drug. Study visits will take
place at the site every 6 months.
Up to thirty-four (34) patients at multiple centers will take part in this study in the
United States.
;
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT06262737 -
Single-center Study Measuring OSDI Dry Eye Score in Patients Undergoing an Anti-VEGF Induction Protocol
|
||
Completed |
NCT02540954 -
Efficacy and Safety of Two Different Aflibercept Regimens in Subjects With Neovascular Age-related Macular Degeneration (nAMD)
|
Phase 3 | |
Completed |
NCT00385333 -
Metabolic Mapping to Measure Retinal Metabolism
|
Phase 2 | |
Completed |
NCT02510794 -
Study of the Efficacy and Safety of the Ranibizumab Port Delivery System for Sustained Delivery of Ranibizumab in Patients With Subfoveal Neovascular Age-Related Macular Degeneration
|
Phase 2 | |
Completed |
NCT02181504 -
A Study of Abicipar Pegol in Japanese Patients With Neovascular Age-related Macular Degeneration
|
Phase 2 | |
Completed |
NCT02390245 -
Philadelphia Telemedicine Glaucoma Detection and Follow-Up Study
|
N/A | |
Terminated |
NCT02228304 -
Study of the Intravitreal Implantation of NT-503-3 Encapsulated Cell Technology (ECT) for the Treatment of Recurrent Choroidal Neovascularization (CNV) Secondary to Age-related Macular Degeneration (AMD)
|
Phase 1/Phase 2 | |
Recruiting |
NCT01521065 -
An Open-label Study to Evaluate the Clinical and Economic Benefits of I-Ray in Patients With Choroidal Neovascularization Secondary to Age-related Macular Degeneration
|
Phase 2 | |
Completed |
NCT01204541 -
A Single-Center Pilot Study to Assess Macular Function
|
N/A | |
Completed |
NCT00769392 -
Pilot Study: A Randomized Trial Of Anesthetic Agents For Intravitreal Injection
|
N/A | |
Completed |
NCT00533520 -
Evaluation of Dosing Interval of Higher Doses of Ranibizumab
|
Phase 4 | |
Completed |
NCT00536016 -
A Phase 1 Safety Study of Single and Repeated Doses of JSM6427 (Intravitreal Injection) to Treat AMD
|
Phase 1 | |
Withdrawn |
NCT00538538 -
Subretinal Lucentis for Hemorrhagic Age-related Macular Degeneration (AMD)
|
Phase 1 | |
Terminated |
NCT00403442 -
Bevacizumab in Combination With Verteporfin Reduced and Standard Fluence in the Treatment of Hemorrhaged Lesions in Neovascular AMD
|
Phase 1 | |
Recruiting |
NCT00157976 -
Double-Masked Study of Photrex (Rostaporfin) Photodynamic Therapy in the Treatment of Age-Related Macular Degeneration
|
Phase 3 | |
Completed |
NCT00239928 -
Clinical Study Of Pegaptanib Sodium (EYE001) For Wet-Type Age-Related Macular Degeneration
|
Phase 2 | |
Completed |
NCT00211458 -
Treatment of Age-Related Macular Degeneration With Anecortave Acetate
|
Phase 2 | |
Completed |
NCT00242580 -
A Safety and Efficacy Study Comparing the Combination Treatments of Verteporfin Therapy Plus One of Two Different Doses of Intravitreal Triamcinolone Acetonide and the Verteporfin Therapy Plus Intravitreal Pegaptanib
|
Phase 3 | |
Completed |
NCT00095433 -
Extension Study of rhuFab V2 in Subjects With Neovascular Age-Related Macular Degeneration (AMD)
|
Phase 3 | |
Completed |
NCT00006202 -
Lutein for Age-Related Macular Degeneration
|
Phase 2 |