Safety and Tolerability of Intravitreal VEGF Trap Formulations in Subjects With Neovacular AMD
This study has been completed.
Sponsor:
Regeneron Pharmaceuticals
Information provided by:
Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00383370
First received: October 2, 2006
Last updated: April 20, 2011
Last verified: April 2011
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Purpose
To assess the safety and tolerability of repeated intravitreal (ITV) administration of VEGF Trap.
| Condition | Intervention | Phase |
|---|---|---|
|
Neovascular Age Related Macular Degeneration |
Drug: VEGF Trap Biological: VEGF Trap |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | A Trial to Assess the Safety and Tolerability of Repeated Doses of Intravitreal Administration of Two VEGF Trap Formulations in Subjects With Neovascular Age Related Macular Degeneration |
Resource links provided by NLM:
Genetics Home Reference related topics:
age-related macular degeneration
tumor necrosis factor receptor-associated periodic syndrome
X-linked juvenile retinoschisis
MedlinePlus related topics:
Macular Degeneration
Drug Information available for:
Aflibercept
U.S. FDA Resources
Further study details as provided by Regeneron Pharmaceuticals:
Primary Outcome Measures:
- The primary endpoint of the study will be safety and tolerability of the study treatment at Week 12 as assessed by ophthalmic examination and reporting of AEs. [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
| Enrollment: | 20 |
| Study Start Date: | October 2006 |
| Study Completion Date: | July 2008 |
| Primary Completion Date: | September 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: ITV-1
VEGF Trap formulation 1
|
Drug: VEGF Trap
VEGF Trap formulation 1, ITV-1
Other Name: ITV-1
|
|
Experimental: ITV-2
VEGF Trap formulation 2
|
Drug: VEGF Trap
VEGF Trap formulation 1, ITV-1
Other Name: ITV-1
|
|
Experimental: ITV-2 OL
VEGF Trap formulation 2 open label, higher concentration
|
Biological: VEGF Trap
VEGF Trap formulation 2 at higher concentration in Open label cohort
Other Name: ITV-2
|
Detailed Description:
A double-masked study in which approximately 12 subjects will receive ITV injections of VEGF Trap every 4 weeks for a total of 3 doses. Once the subjects have received the 3 doses allowed in this study, they will be evaluated every 4 weeks for continued dosing of VEGF Trap for an additional 9 months.
Eligibility| Ages Eligible for Study: | 50 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Subfoveal CNV secondary to AMD.
- Central retinal (including lesion) thickness ≥ 250 µm as measured by OCT.
- ETDRS best-corrected visual acuity (BCVA) of 20/40 to 20/400 (73 to 20 letters)
Exclusion Criteria:
No prior treatment with the following in the study eye:
- Subfoveal thermal laser therapy;
- Submacular surgery or other surgical intervention for the treatment of AMD;
- Extrafoveal laser coagulation treatment within 12 weeks prior to Day 1 (Visit 2);
- PDT or ITV administration of triamcinolone acetonide or any other steroid within 12 weeks prior to Day 1 (Visit 2);
- Pegaptanib sodium within 8 weeks of Day 1 (Visit 2);
- Juxtascleral steroids or anecortave acetate within 180 Days (6 months) prior to Day 1 (visit 2);
- Prior systemic or intravitreal treatment with VEGF Trap or bevacizumab;
- Any investigational agent for the treatment of eye disease within 12 weeks of Day 1 (Visit 2)
- History of any vitreous hemorrhage within 4 weeks prior to baseline injection visit.
- Aphakia or pseudophakia with the absence of a posterior capsule (unless it occurred as a result of a yttrium aluminum garnet [YAG] capsulotomy).
- Significant subfoveal atrophy or scarring.
- Any condition or laboratory abnormality that, in the opinion of the Investigator, would interfere with the assessment of disease status/progression or jeopardize the subject's appropriate participation in this study
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00383370
Locations
| United States, Florida | |
| Fort Myers, Florida, United States, 33907 | |
| United States, Kansas | |
| Wichita, Kansas, United States, 67214 | |
| United States, Maryland | |
| Hagerstown, Maryland, United States, 21740 | |
| United States, South Carolina | |
| Columbia, South Carolina, United States, 29169 | |
| United States, Texas | |
| Austin, Texas, United States, 78705 | |
| McAllen, Texas, United States, 78503 | |
Sponsors and Collaborators
Regeneron Pharmaceuticals
Investigators
| Study Director: | Avner Ingerman, MD | Regeneron Pharmaceutical |
More Information
No publications provided
| Responsible Party: | Avner Ingerman, MD, Regeneron Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT00383370 History of Changes |
| Other Study ID Numbers: | VGFT-OD-0603 |
| Study First Received: | October 2, 2006 |
| Last Updated: | April 20, 2011 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Macular Degeneration Wet Macular Degeneration Retinal Degeneration Retinal Diseases Eye Diseases |
ClinicalTrials.gov processed this record on May 16, 2013