To Evaluate The Role of Intravitreal Aflibercept Injection (2.0 mg) in the Management of Previously Treated Patients With Exudative AMD

NCT ID: NCT01495221

Last Updated: 2018-09-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 9 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-12-31
• Study Completion Date: 2013-03-31

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.

Conditions

AMD (With Persistent or Recurrent Fluid Despite Monthly Intravitreal Anti-VEGF Therapy)

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Intravitreal aflibercept

All eligible patients will receive intravitreal aflibercept injection (2.0mg) every 4 weeks (monthly) for the first 12 weeks (3 months), followed by 2 mg once every 8 weeks (2 months) through Week 24. Patients can be dosed as frequently as 2 mg every 4 weeks (monthly) upon investigator discretion.

Group Type: OTHER

Alfilbercept

Intervention Type: DRUG

All patients will receive 2.0 mg intravitreal aflibercept injection.

Interventions

Alfilbercept

All patients will receive 2.0 mg intravitreal aflibercept injection.

Intervention Type: DRUG

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

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Vitreous -Retina- Macula Consultants of New York

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Vitreous Retina Macula Consultants of New York

New York, New York, United States

Countries

United States

Other Identifiers

HOLD STUDY

Identifier Type: -

Identifier Source: org_study_id