Clinical trial NCT00320788: Safety and Efficacy of Repeated Intravitreal Administration of Vascular Endothelial Growth Factor (VEGF) Trap in Patients With Wet Age-Related Macular Degeneration (AMD)
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Macular Degeneration
Keywords: Neovascular Age-Related Macular Degeneration
Lead sponsor: Regeneron Pharmaceuticals
Sponsor class: INDUSTRY
Collaborators: name: Bayer
First posted: 2006-05-03
Enrollment: 159
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Mean Change of CR/LT From Baseline at Week 12
timeFrame: Baseline and at Week 12
Secondary outcomes:
measure: Mean Percent Change of CR/LT From Baseline at Week 12
timeFrame: Baseline and at Week 12
measure: Mean Change in Best Corrected Visual Acuity (BCVA) as Measured by Early Treatment Diabetic Retinopathy Study (ETDRS) From Baseline at Week 12
timeFrame: Baseline and at week 12
measure: Percentage of Participants Who Gained at Least 15 Letters of Vision in the ETDRS Letter Score From Baseline at Week 12
timeFrame: At Week 12
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Associated Retina Consultants
state: Arizona
city: Tucson
country: United States
facility: Retina Centers, PC
state: Arizona
city: Beverly Hills
country: United States
facility: Retina Vitreous Associates Medical Group
state: California
city: Loma Linda
country: United States
facility: Loma Linda University Health Care
state: California
city: Augusta
country: United States
facility: Southeast Retina Center
state: Georgia
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
city: Indianapolis
country: United States
facility: Midwest Eye Institute
state: Indiana
city: Baltimore
country: United States
facility: Johns Hopkins Hospital School of Medicine
state: Maryland
city: Boston
country: United States
facility: Ophthalmic Consultants of Boston
state: Massachusetts
city: West Springfield
country: United States
facility: New England Retina Consultants PC
state: Massachusetts
city: Charlotte
country: United States
facility: Charlotte Eye, Ear, Nose & Throat Asssociates
state: North Carolina
city: Oklahoma City
country: United States
facility: Dean A. McGee Eye Institute
state: Oklahoma
city: Portland
country: United States
facility: Retina Northwest PC
state: Oregon
city: Philadelphia
country: United States
facility: Retina Diagnostic and Treatment Assoc., LLC
state: Pennsylvania
city: Rapid City
country: United States
facility: Black Hills Regional Eye Institute
state: South Dakota
city: Nashville
country: United States
facility: Retina-Vitreous Associates, P.C.
state: Tennessee
city: Houston
country: United States
facility: Vitreoretinal Consultants Scurlock Tower Texas Medical Center
state: Texas
city: San Antonio
country: United States
facility: Medical Center Ophthamology
state: Texas
Study officials:
affiliation: Regeneron Pharmaceuticals
name: Clinical Trial Management
role: STUDY_DIRECTOR
References:
citation: Li E, Donati S, Lindsley KB, Krzystolik MG, Virgili G. Treatment regimens for administration of anti-vascular endothelial growth factor agents for neovascular age-related macular degeneration. Cochrane Database Syst Rev. 2020 May 5;5(5):CD012208. doi: 10.1002/14651858.CD012208.pub2.