Safety and Tolerability of Intravitreal VEGF Trap Formulations in Subjects With Neovacular AMD

NCT00383370 | Completed Phase 1

• 1 other identifier: VGFT-OD-0603
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 6

Brief Summary

To assess the safety and tolerability of repeated intravitreal (ITV) administration of VEGF Trap.

Conditions

Neovascular Age Related Macular Degeneration

Outcome Measures

Primary Outcomes (1)

• 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.

  12 weeks

Study Arms (3)

ITV-1

EXPERIMENTAL

VEGF Trap formulation 1

Drug: VEGF Trap

ITV-2

EXPERIMENTAL

VEGF Trap formulation 2

Drug: VEGF Trap

ITV-2 OL

EXPERIMENTAL

VEGF Trap formulation 2 open label, higher concentration

Biological: VEGF Trap

Interventions

VEGF Trap DRUG

VEGF Trap formulation 1, ITV-1

Also known as: ITV-1

ITV-1; ITV-2

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Regeneron Pharmaceuticals: lead

Study Sites (6)

Unknown Facility

Fort Myers, Florida, 33907, United States

Location

Unknown Facility

Wichita, Kansas, 67214, United States

Location

Unknown Facility

Hagerstown, Maryland, 21740, United States

Location

Unknown Facility

Columbia, South Carolina, 29169, United States

Location

Unknown Facility

Austin, Texas, 78705, United States

Location

Unknown Facility

McAllen, Texas, 78503, United States

Location

MeSH Terms

Interventions

aflibercept

Study Officials

• Avner Ingerman, MD

  Regeneron Pharmaceutical

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: October 2, 2006
• First Posted: October 3, 2006
• Study Start: October 1, 2006
• Primary Completion: September 1, 2007
• Study Completion: July 1, 2008
• Last Updated: April 21, 2011

Record last verified: 2011-04

Locations

US (6)