To Evaluate tHe rOle of Intravitreal Aflibercept Injection (2.0 mg) in the Management of previousLy Treated Patients With Exudative AMD
The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2012 by Vitreous -Retina- Macula Consultants of New York.
Recruitment status was Recruiting
Information provided by (Responsible Party):
Vitreous -Retina- Macula Consultants of New York
First received: December 15, 2011
Last updated: June 21, 2012
Last verified: June 2012
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.
AMD Who Have Persistent or Recurrent Fluid Despite Monthly Intravitreal Anti-VEGF Therapy.
||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||To Evaluate tHe rOle of Intravitreal Aflibercept Injection (2.0 mg) in the Management of previousLy Treated Patients With Exudative AMD
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:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||May 2013 (Final data collection date for primary outcome measure)
|Ages Eligible for Study:
||50 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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
- 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01495221
|Vitreous Retina Macula Consultants of New York
|New York, New York, United States, 10022 |
|Principal Investigator: Jason S Slakter, MD |
Vitreous -Retina- Macula Consultants of New York
No publications provided
ClinicalTrials.gov processed this record on September 18, 2014
||Vitreous -Retina- Macula Consultants of New York
History of Changes
|Other Study ID Numbers:
|Study First Received:
||December 15, 2011
||June 21, 2012
||United States: Institutional Review Board