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

Phase 1

Completed

• Conditions: Neovascular Age Related Macular Degeneration
• Interventions: Biological: VEGF Trap

• Registration Number: NCT00383370
• Lead Sponsor: Regeneron Pharmaceuticals

Brief Summary

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

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.

Study Timeline

• Study Start: 2006-10
• Study First Submitted: 2006-10-02
• Study First Submitted QC: 2006-10-02
• Study First Posted: 2006-10-03
• Primary Completion: 2007-09
• Study Completion: 2008-07
• Status Verified: 2011-04
• Last Update Submitted: 2011-04-20
• Last Update Posted: 2011-04-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ITV-1	VEGF Trap	VEGF Trap formulation 1
ITV-2	VEGF Trap	VEGF Trap formulation 2
ITV-2 OL	VEGF Trap	VEGF Trap formulation 2 open label, higher concentration

Primary Outcome Measures

Name	Time	Method
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