Safety and Efficacy of Repeated Intravitreal Administration of Vascular Endothelial Growth Factor (VEGF) Trap in Patients With Wet Age-Related Macular Degeneration (AMD)

Macular Degeneration Clinical Trial

Official title:

A Randomized, Controlled Study of the Safety, Tolerability and Biological Effect of Repeated Intravitreal Administration of VEGF Trap in Patients With Neovascular Age-Related Macular Degeneration

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00320788
• Other study ID #: VGFT-OD-0508
• Status: Completed
• Phase: Phase 2
• First received: April 28, 2006
• Last updated: January 27, 2012
• Start date: April 2006
• Est. completion date: August 2008

Study information

• Verified date: January 2012
• Source: Regeneron Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This study examines the effect of intravitreally administered VEGF Trap in patients with wet AMD.

The purpose of this trial is to assess the ocular and systemic safety and tolerability of repeated intravitreal doses of VEGF Trap in patients with subfoveal choroidal neovascularization (CNV) due to AMD.

Description:

This is a double masked, prospective, randomized study in which five groups of approximately 30 patients meeting the eligibility criteria will be randomly assigned in a balanced ratio to receive a series of intravitreal (IVT) injections of VEGF Trap into the study eye at 4- or 12 -week intervals over a 12-week period.

After Week 12, patients will be evaluated every 4 weeks. Patients will remain on study or may be eligible to enter a long-term extension study, in which they will continue to receive VEGF Trap.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 159
• Est. completion date: August 2008
• Est. primary completion date: June 2008
• 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 = 300 µm as measured by Optical Coherence Tomography (OCT).

• Early Treatment of Diabetic Retinopathy Study (ETDRS) best-corrected visual acuity of 73 letters to 34 letters.

Exclusion Criteria:

• History of any vitreous hemorrhage within 4 weeks prior to Day 1.

• Aphakia.

• Significant subfoveal atrophy or scarring.

• 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.

• Photodynamic therapy (PDT) within 12 weeks prior to Visit 2 (Day 1).

• Pegaptanib sodium (Macugen) within 8 weeks of Visit 2 (Day 1).

• Juxtascleral steroids or anecortave acetate within 24 weeks (6 months) prior to Visit 2 (Day 1).

• Intravitreal administration of triamcinolone acetonide or other steroids within 24 weeks prior to Visit 2 (Day 1), unless no visible residue of drug substance can be seen in the vitreous cavity using indirect ophthalmoscopy.

• Prior systemic or intravitreal treatment with VEGF Trap, ranibizumab (Lucentis) or bevacizumab (Avastin).

• Presence of any other condition or laboratory abnormality, which, in the opinion of the Investigator, would interfere with the assessment of disease status/progression or jeopardize the patient's appropriate participation in this Phase II study.

Study Design

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

Related Conditions & MeSH terms

• Macular Degeneration
• Wet Macular Degeneration

Intervention

Biological:
• aflibercept injection (VEGF Trap-Eye, BAY86-5321)
Participants received 0.5 mg of aflibercept injection (VEGF Trap-Eye, BAY86-5321) at 4 week intervals through Week 12
• aflibercept injection (VEGF Trap-Eye, BAY86-5321)
Participants received 0.5 mg of aflibercept injection (VEGF Trap-Eye, BAY86-5321) at 12 week intervals through Week 12.
• aflibercept injection (VEGF Trap-Eye, BAY86-5321)
Participants received 2.0 mg of aflibercept injection (VEGF Trap-Eye, BAY86-5321) at 4 week intervals through Week 12
• aflibercept injection (VEGF Trap-Eye, BAY86-5321)
Participants received 2.0 mg of aflibercept injection (VEGF Trap-Eye, BAY86-5321) at 12 week intervals through Week 12.
• aflibercept injection (VEGF Trap-Eye, BAY86-5321)
Participants received 4.0 mg of aflibercept injection (VEGF Trap-Eye, BAY86-5321) at 12 week intervals through Week 12.

Locations

Country	Name	City	State
United States	Southeast Retina Center	Augusta	Georgia
United States	Johns Hopkins Hospital School of Medicine	Baltimore	Maryland
United States	Retina Vitreous Associates Medical Group	Beverly Hills	California
United States	Ophthalmic Consultants of Boston	Boston	Massachusetts
United States	Charlotte Eye, Ear, Nose & Throat Asssociates	Charlotte	North Carolina
United States	University of Chicago	Chicago	Illinois
United States	Vitreoretinal Consultants Scurlock Tower Texas Medical Center	Houston	Texas
United States	Midwest Eye Institute	Indianapolis	Indiana
United States	Loma Linda University Health Care	Loma Linda	California
United States	Retina-Vitreous Associates, P.C.	Nashville	Tennessee
United States	Dean A. McGee Eye Institute	Oklahoma City	Oklahoma
United States	Retina Diagnostic and Treatment Assoc., LLC	Philadelphia	Pennsylvania
United States	Associated Retina Consultants	Phoenix	Arizona
United States	Retina Northwest PC	Portland	Oregon
United States	Black Hills Regional Eye Institute	Rapid City	South Dakota
United States	Medical Center Ophthamology	San Antonio	Texas
United States	Retina Centers, PC	Tucson	Arizona
United States	New England Retina Consultants PC	West Springfield	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Regeneron Pharmaceuticals	Bayer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean Change of CR/LT From Baseline at Week 12	CR/LT measured in micrometers (µm); lower individual values represent better outcomes.	Baseline and at Week 12	No
Secondary	Mean Percent Change of CR/LT From Baseline at Week 12	CR/LT measured in micrometers (µm); a more negative percentage represents a better outcome	Baseline and at Week 12	No
Secondary	Mean Change in Best Corrected Visual Acuity (BCVA) as Measured by Early Treatment Diabetic Retinopathy Study (ETDRS) From Baseline at Week 12	Defined study baseline range of ETDRS Best Corrected Visual Acuity of: letter score of 73 to 25 (20/40 to 20/320) in the study eye; a higher score represents better functioning	Baseline and at week 12	No
Secondary	Percentage of Participants Who Gained at Least 15 Letters of Vision in the ETDRS Letter Score From Baseline at Week 12	Defined study baseline range of ETDRS Best Corrected Visual Acuity of: letter score of 73 to 25 (20/40 to 20/320) in the study eye; a higher score represents better functioning	At Week 12	No

External Links

•   Primary endpoint results of a phase II study of vascular endothelial growth factor trap-eye in wet age-related macular degeneration.
•   The 1-year results of CLEAR-IT 2, a phase 2 study of vascular endothelial growth factor trap-eye dosed as-needed after 12-week fixed dosing.