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Short-term Clinical Effects of Intravitreal Aflibercept Injection 2.0mg as a Predictor of Long-term Results

NCT ID: NCT01657669

Last Updated: 2017-10-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-10-31

Study Completion Date

2017-12-31

Brief Summary

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This is an open label study to evaluate 2.0 mg intravitreal aflibercept injection administered in subject who have active choroidal neovascularization due to Age Related Macular Degeneration (AMD).

Detailed Description

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Twenty (20) consented participant who meet the inclusion criteria will be enrolled to be followed for 48 weeks. All subjects will receive 2.0 mg intravitreal aflibercept injections with three initial monthly doses, and mandatory doses at Weeks 16, 24, 32, and 40. Dosing at monthly intervals is allowed if needed in the opinion of the investigator based on presence of fluid on Optical Coherence Tomography (OCT) and/or a decrease in visual acuity of greater than or equal to 5 letters from the best previous visit. Only one eye will be enrolled in the study.

Conditions

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Age Related Macular Degeneration

Keywords

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Choroidal neovascularization due to AMD

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Intravitreal Aflibercept injection

Intravitreal Aflibercept injection 2.0 mg dosed every 4 weeks (monthly) for the first 3 months followed by 2.0 mg (0.05mg) via intravitreal injection once every 8 weeks (2 months).

Group Type OTHER

Intravitreal Aflibercept injection

Intervention Type DRUG

Intravitreal Aflibercept injection 2.0 mg dosed every 4 weeks (monthly) for the first 3 months followed by 2.0 mg (0.05mL) via intravitreal injection once every 8 weeks (2 months). Dosing at monthly intervals is allowed if needed in the opinion of the investigator based on presence of fluid on OCT and/or a decrease in visual acuity of 5 letters or more from the best previous visit.

Interventions

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Intravitreal Aflibercept injection

Intravitreal Aflibercept injection 2.0 mg dosed every 4 weeks (monthly) for the first 3 months followed by 2.0 mg (0.05mL) via intravitreal injection once every 8 weeks (2 months). Dosing at monthly intervals is allowed if needed in the opinion of the investigator based on presence of fluid on OCT and/or a decrease in visual acuity of 5 letters or more from the best previous visit.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

Ability to provide written informed consent and comply with study assessments for the full duration of the study.

Age 50 years and above.

Choroidal neovascularization secondary to AMD with central retinal thickness greater than or equal to 300um.

Best corrected visual acuity in the study eye between 20/40 and 20/400 using an ETDRS chart -

Exclusion Criteria

Pregnancy (positive urine 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 a study or an investigational drug or device within the past 30 days prior to enrolling in the study.

Presence of significant subfoveal fibrosis or atrophy.

Previously treated subjects:

Prior treatment with anti-VEGF therapy in the study eye within 28 days of baseline More than six (6) prior treatments with anti-VEGF therapy in the study eye within 1 year.

Prior treatment with PDT within the past 3 months or more than 2 prior PDT treatments.

Prior treatment with intravitreal aflibercept injection Prior treatment with triamcinolone in the study eye within 6 months of baseline.

Prior treatment with dexamethasone in the study eye within 30 days prior to baseline.

Intraocular surgery (including cataract surgery)in the study eye within 2 months preceding baseline

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.

Active infectious conjunctivitis, keratitis, scleritis, or endophthalmitis in either eye.

Uncontrolled glaucoma in the study eye (defined as IOP greater than or equal to 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

History of retinal pigment epithelial tear or rip.

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Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Valley Retina Institute

OTHER

Sponsor Role collaborator

Retina Research Institute, LLC

OTHER

Sponsor Role lead

Responsible Party

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Rhonda Weeks

Gaurav K. Shah, MD, Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Gaurav K. Shah, MD

Role: PRINCIPAL_INVESTIGATOR

The Retina Institute

Locations

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The Retina Institute

St Louis, Missouri, United States

Site Status

The Retina Institute

St Louis, Missouri, United States

Site Status

Valley Retina Institute

McAllen, Texas, United States

Site Status

Countries

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United States

References

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Liu EM, Shah G, Blinder KJ, Smith BT, Thomas MA. Intravitreal Aflibercept for Neovascular AMD: Short-Term Clinical Effects of Intravitreal Aflibercept Injection as a Predictor of Long-Term Results. Ophthalmic Surg Lasers Imaging Retina. 2015 Nov-Dec;46(10):1021-7. doi: 10.3928/23258160-20151027-06.

Reference Type DERIVED
PMID: 26599244 (View on PubMed)

Other Identifiers

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GS-01-12

Identifier Type: -

Identifier Source: org_study_id