Clinical trial NCT01495221: To Evaluate The Role of Intravitreal Aflibercept Injection (2.0 mg) in the Management of Previously Treated Patients With Exudative AMD
Official title: To Evaluate The Role of Intravitreal Aflibercept Injection (2.0 mg) in the Management of Previously Treated Patients With Exudative AMD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: AMD (With Persistent or Recurrent Fluid Despite Monthly Intravitreal Anti-VEGF Therapy)
Lead sponsor: Vitreous -Retina- Macula Consultants of New York
Sponsor class: OTHER
First posted: 2011-12-19
Enrollment: 9
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility 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

Primary outcomes:
measure: Proportion of Patients With no Fluid on OCT at Week 24
timeFrame: 24 week
measure: Mean Change in Visual Acuity From Baseline to Week 16
timeFrame: Baseline to Week 16
Secondary outcomes:
measure: Mean Change in OCT Central Retinal Lesion Thickness From Baseline to Week 16
timeFrame: Baseline and week 16
measure: Mean Change in OCT Greatest Height of Pigment Epithelial Detachment From Baseline to Week 16
timeFrame: Baseline and 16 weeks
Other outcomes:
Locations:
city: New York
country: United States
facility: Vitreous Retina Macula Consultants of New York
state: New York
Study officials:
References: