Completed

NCT Number: NCT01495221

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

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.

Completed

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Key information

Conditions

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

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Vitreous Retina Macula Consultants of New York

New York, 10022, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Alfilbercept

Drug

All patients will receive 2.0 mg intravitreal aflibercept injection.

Primary outcomes

Proportion of Patients With no Fluid on OCT at Week 24

Time frame: 24 week

No primary outcome data can be found or provided.
Mean Change in Visual Acuity From Baseline to Week 16

Time frame: Baseline to Week 16

Visual acuity was documented via BCVA at every study visit.

Secondary outcomes

Mean Change in OCT Central Retinal Lesion Thickness From Baseline to Week 16

Time frame: Baseline and week 16

OCT is performed on the Spectralis spectral domain OCT machine (Heidelberg Engineering, Germany). The OCT is centered on the fovea. The OCT examination will use the 19 scan mode on the Spectralis averaging at least 25 images per scan. Follow-up visits will use the follow-up protocol on the Spectralis , automatically placing follow-up scans in precisely the same location as the baseline scan.
Mean Change in OCT Greatest Height of Pigment Epithelial Detachment From Baseline to Week 16

Time frame: Baseline and 16 weeks

OCT is performed on the Spectralis spectral domain OCT machine (Heidelberg Engineering, Germany). The OCT is centered on the fovea. The OCT examination will use the 19 scan mode on the Spectralis averaging at least 25 images per scan. Follow-up visits will use the follow-up protocol on the Spectralis , automatically placing follow-up scans in precisely the same location as the baseline scan.

Sponsors and collaborators

Lead sponsor

Vitreous -Retina- Macula Consultants of New York

Other

Registry information

Important dates

Study start: 2011
Primary completion: 2013
Study completion: 2013
First posted: Dec 19, 2011
Registry last updated: Sep 7, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.