![]() |
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
Sponsors and Collaborators: |
Regeneron Pharmaceuticals Bayer Schering Pharmaceutical |
---|---|
Information provided by: | Regeneron Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00320775 |
The purpose of this trial is to assess the ocular and systemic safety and tolerability of a single intravitreal injection of VEGF Trap in patients with subfoveal choroidal neovascularization (CNV) due to AMD.
Condition | Intervention | Phase |
---|---|---|
Macular Degeneration |
Drug: VEGF Trap |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Dose Comparison, Parallel Assignment, Safety/Efficacy Study |
Official Title: | An Exploratory Study of the Safety, Tolerability and Biological Effect of Intravitreal Administration of VEGF Trap in Patients With Neovascular Age-Related Macular Degeneration |
Enrollment: | 51 |
Study Start Date: | June 2005 |
Study Completion Date: | August 2008 |
Primary Completion Date: | June 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
Part A: Experimental
Part A: An open label study in which six successive cohorts of 3-6 patients each with neovascular AMD will receive a single intravitreal (ITV) injection of 0.05, 0.15, 0.5, 1.0, 2.0, or 4.0 mg of VEGF Trap into the study eye. The total volume of each injection will be 100 μL. Enrollment in new dose levels will not begin until all patients in the preceding dose level have completed Visit 5 (Day 15).
|
Drug: VEGF Trap
Part A: Six successive cohorts of 3-6 patients each with neovascular AMD will receive a single intravitreal (ITV) injection of 0.05, 0.15, 0.5, 1.0, 2.0, or 4.0 mg of VEGF Trap into the study eye. Part B: Up to 30 subjects will be randomly assigned in a 1:1 ratio to receive a single of 2.0 mg/eye VEGF Trap followed by 1 sham injection six weeks later, or an initial dose of 0.3 mg pegaptanib sodium into the study eye, followed by a second dose six weeks later. Part C: Approximately 30 subjects will be randomly assigned in a 1:1 ratio to receive up to two ITV injections of either 0.15 or 4.0 mg/eye VEGF Trap. After completion of Visit 8 (Day 57), patients from all parts of the study, may be eligible to continue in Open-label Extension and will receive 4.0 mg of VEGF Trap. |
Part B: Active Comparator
Part B: A controlled, prospective, randomized, double-masked study in which up to 30 subjects meeting eligibility criteria will be randomly assigned in a 1:1 ratio to receive a single ITV injection of2.0 mg/eye VEGF Trap (or the MTD if reached prior to 2.0 mg) followed by 1 sham injection six weeks later, or an initial dose of 0.3 mg pegaptanib sodium into the study eye, followed by a second dose six weeks later. Enrollment into Part B will begin 2 weeks after the last subject to receive the 2.0 mg/eye dose in Part A has been observed for 15 days and it has been determined that the safety profile of VEGF Trap at this dose level is adequate to support expansion of dosing at this dose level. The dose of pegaptanib sodium will be 0.3 mg, according to the package insert.
|
Drug: VEGF Trap
Part A: Six successive cohorts of 3-6 patients each with neovascular AMD will receive a single intravitreal (ITV) injection of 0.05, 0.15, 0.5, 1.0, 2.0, or 4.0 mg of VEGF Trap into the study eye. Part B: Up to 30 subjects will be randomly assigned in a 1:1 ratio to receive a single of 2.0 mg/eye VEGF Trap followed by 1 sham injection six weeks later, or an initial dose of 0.3 mg pegaptanib sodium into the study eye, followed by a second dose six weeks later. Part C: Approximately 30 subjects will be randomly assigned in a 1:1 ratio to receive up to two ITV injections of either 0.15 or 4.0 mg/eye VEGF Trap. After completion of Visit 8 (Day 57), patients from all parts of the study, may be eligible to continue in Open-label Extension and will receive 4.0 mg of VEGF Trap. |
Part C: Active Comparator
Part C: A controlled, prospective, randomized, double-masked study in which approximately 30 subjects meeting eligibility criteria will be randomly assigned in a 1:1 ratio to receive up to two ITV injections of either 0.15 or 4.0 mg/eye VEGF Trap. Initiation of Part C is contingent upon the 4.0 mg dose being adequately tolerated in Part A.
|
Drug: VEGF Trap
Part A: Six successive cohorts of 3-6 patients each with neovascular AMD will receive a single intravitreal (ITV) injection of 0.05, 0.15, 0.5, 1.0, 2.0, or 4.0 mg of VEGF Trap into the study eye. Part B: Up to 30 subjects will be randomly assigned in a 1:1 ratio to receive a single of 2.0 mg/eye VEGF Trap followed by 1 sham injection six weeks later, or an initial dose of 0.3 mg pegaptanib sodium into the study eye, followed by a second dose six weeks later. Part C: Approximately 30 subjects will be randomly assigned in a 1:1 ratio to receive up to two ITV injections of either 0.15 or 4.0 mg/eye VEGF Trap. After completion of Visit 8 (Day 57), patients from all parts of the study, may be eligible to continue in Open-label Extension and will receive 4.0 mg of VEGF Trap. |
This study consists of three parts, Part A, Part B and Part C. Part A is a dose escalation. Part B was terminated early. The (one) subject who received Macugen is not discussed in this website. Part C had subjects receive one of two doses of VEGF Trap (0.15 mg or 4.0 mg).
This is the first study in which human subjects received intravitreal injections of VEGF Trap in a study eye.
Ages Eligible for Study: | 50 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
ETDRS best-corrected visual acuity of:
Exclusion Criteria:
United States, Arizona | |
Retina Centers, PC | |
Tuscon, Arizona, United States, 85704 | |
United States, California | |
Loma Linda University Health Care | |
Loma Linda, California, United States, 92354 | |
United States, Illinois | |
University of Chicago | |
Chicago, Illinois, United States, 60637 | |
United States, Maryland | |
Johns Hopkins Hospital School of Medicine | |
Baltimore, Maryland, United States, 21287 | |
United States, North Carolina | |
Charlotte Eye, Ear, Nose & Throat Asssociates | |
Charlotte, North Carolina, United States, 28120 | |
United States, Oklahoma | |
Dean A. McGee Eye Institute | |
Oklahoma City, Oklahoma, United States, 73104 | |
United States, Pennsylvania | |
Retina Diagnostic and Treatment Assoc., LLC | |
Philadelphia, Pennsylvania, United States, 19107 | |
United States, Tennessee | |
Retina-Vitreous Associates, P.C. | |
Nashville, Tennessee, United States, 37203 |
Study Director: | Avner Ingerman, MD | Regeneron Pharmaceuticals |
Responsible Party: | Regeneron Pharmaceuticals Inc. ( Avner Ingerman MD/ Study Director ) |
Study ID Numbers: | VGFT-OD-0502 |
Study First Received: | April 28, 2006 |
Last Updated: | April 29, 2009 |
ClinicalTrials.gov Identifier: | NCT00320775 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Neovascular Age-Related Macular Degeneration |
Eye Diseases Retinal Degeneration Macular Degeneration Retinal Diseases |
Eye Diseases Retinal Degeneration Macular Degeneration Retinal Diseases |