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

Neovascular Age Related Macular Degeneration Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00383370
• Other study ID #: VGFT-OD-0603
• Status: Completed
• Phase: Phase 1
• First received: October 2, 2006
• Last updated: April 20, 2011
• Start date: October 2006
• Est. completion date: July 2008

Study information

• Verified date: April 2011
• Source: Regeneron Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: July 2008
• Est. primary completion date: September 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Macular Degeneration
• Neovascular Age Related Macular Degeneration
• Wet Macular Degeneration

Intervention

Drug:
• VEGF Trap
VEGF Trap formulation 1, ITV-1

Biological:
• VEGF Trap
VEGF Trap formulation 2 at higher concentration in Open label cohort

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Regeneron Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes