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To Evaluate tHe rOle of Intravitreal Aflibercept Injection (2.0 mg) in the Management of previousLy Treated Patients With Exudative AMD

This study is currently recruiting participants.
Verified June 2012 by Vitreous -Retina- Macula Consultants of New York
Sponsor:
Information provided by (Responsible Party):
Vitreous -Retina- Macula Consultants of New York
ClinicalTrials.gov Identifier:
NCT01495221
First received: December 15, 2011
Last updated: June 21, 2012
Last verified: June 2012
History of Changes
  Purpose

This is an open label study to evaluate intravitreally administered 2.0 mg intravitreal aflibercept injection in patients who have been previously treated for AMD and have persistent or recurrent fluid despite monthly intravitreal anti-VEGF therapy.


Condition Intervention Phase
AMD Who Have Persistent or Recurrent Fluid Despite Monthly Intravitreal Anti-VEGF Therapy.
 Drug: Alfilbercept
 Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: To Evaluate tHe rOle of Intravitreal Aflibercept Injection (2.0 mg) in the Management of previousLy Treated Patients With Exudative AMD

Resource links provided by NLM:

Drug Information available for: Aflibercept
U.S. FDA Resources

Further study details as provided by Vitreous -Retina- Macula Consultants of New York:

Primary Outcome Measures:
  • Proportion of patients with no fluid on OCT at Week 24 [ Time Frame: 24 week ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Proportion of patients no fluid with on OCT at Weeks 12 and 24 [ Time Frame: week 12 and 24 ] [ Designated as safety issue: No ]
    • Mean change in VA from Baseline at Weeks 12, 24 and 48
    • Mean change in central foveal thickness (RPE to ILM) as measured by SD-OCT at Weeks 12, 24 and 48
    • Mean change in leakage as determined by FA at Weeks 24 and 48
    • Mean number of intravitreal aflibercept injections at Week 48
    • Mean duration of fluid-free interval between Weeks 24 and 48
    • Mean change in contrast sensitivity at Week 24 and 48
    • Mean change in microperimetry outcomes at Week 24 and 48
    • Mean change in NEI VFQ score at Week 48


Estimated Enrollment: 30
Study Start Date: December 2011
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Alfilbercept
    All patients will receive 2.0 mg intravitreal aflibercept injection.
  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Ability to provide written informed consent and comply with study assessments for the full duration of the study
  • Age > 50 years
  • Choroidal neovascularization secondary to AMD
  • Best corrected visual acuity in the study eye between 20/25 to 20/400 using an ETDRS chart
  • Documentation of presence of subretinal fluid and/or cystoid macular edema on SD-OCT following at least four anti-VEGF treatments within six months before enrollment and a maximum of 5 years of years of treatment for neovascular AMD
  • Documentation of presence of subretinal fluid and/or cystoid macular edema less than 30 days since last treatment

Exclusion Criteria:

  • Pregnancy (positive pregnancy test) or lactation
  • Premenopausal women not using adequate contraception. The following are considered effective means of contraception: surgical sterilization or use of oral contraceptives, barrier contraception with either a condom or diaphragm in conjunction with spermicidal gel, an IUD, or contraceptive hormone implant or patch.
  • Participation in another simultaneous medical investigation or trial
  • Prior treatment with anti-VEGF therapy in the study eye within 30 days of BSL
  • Prior treatment with PDT within the past 3 months or more than 4 prior PDT treatments.
  • Presence of significant subfoveal fibrosis or atrophy.
  • Prior treatment with intravitreal aflibercept injection
  • Prior treatment with triamcinolone in the study eye within 6 months of BSL.
  • Prior treatment with dexamethasone in the study eye within 30 days prior to BSL
  • Intraocular surgery (including cataract surgery) in the study eye within 2 months preceding BSL
  • History of vitrectomy surgery, submacular surgery, or other surgical intervention for AMD in the study eye
  • Active intraocular inflammation (grade trace or above) in the study eye
  • Current vitreous hemorrhage in the study eye
  • History of rhegmatogenous retinal detachment or macular hole (Stage 3 or 4) in the study eye
  • Ocular or periocular infection
  • Active severe intraocular inflammation
  • Uncontrolled glaucoma in the study eye (defined as IOP ≥ 30 mmHg despite treatment with anti-glaucoma medication)
  • History of cerebral vascular accident, myocardial infarction, transient ischemic attacks within 3 months of study enrollment.
  • History of allergy to fluorescein, ICG or iodine, not amenable to treatment
  • Known hypersensitivity to aflibercept or to any of the excipients
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01495221

Contacts
Contact: May Lee (212) 452-6965 mlee@vrmny.com
Contact: Nishant Kumar, MD 212 861-9797 nishant6377@gmail.com

Locations
United States, New York
Vitreous Retina Macula Consultants of New York Recruiting
New York, New York, United States, 10022
Principal Investigator: Jason S Slakter, MD            
Sponsors and Collaborators
Vitreous -Retina- Macula Consultants of New York
  More Information

No publications provided

Responsible Party: Vitreous -Retina- Macula Consultants of New York
ClinicalTrials.gov Identifier: NCT01495221     History of Changes
Other Study ID Numbers: HOLD STUDY
Study First Received: December 15, 2011
Last Updated: June 21, 2012
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on May 19, 2013