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

Regeneron Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Neovascular Age Related Macular Degeneration

Treatments: Biological: VEGF Trap

Study type: Interventional

Funder types: Industry

Identifiers

NCT00383370

VGFT-OD-0603

Details and patient eligibility

About

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

Full 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.

Enrollment: 20 patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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20 participants in 3 patient groups

ITV-1

Experimental group

Description:

VEGF Trap formulation 1

ITV-2

Experimental group

Description:

VEGF Trap formulation 2

ITV-2 OL

Experimental group

Description:

VEGF Trap formulation 2 open label, higher concentration

Treatment:

Biological: VEGF Trap

Biological: VEGF Trap