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

NCT01657669 | Unknown Phase 4

• 1 other identifier: GS-01-12
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 3

Brief Summary

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).

Conditions

Age Related Macular Degeneration

Keywords

Choroidal neovascularization due to AMD

Outcome Measures

Primary Outcomes (1)

• Resolution time of intraretinal cysts and sub retinal fluid on OCT

  12 months

Secondary Outcomes (8)

• Mean change in OCT central foveal thickness

  12 months

• The percentage of subjects with no fluid on OCT

  12 months

• The percentage of subjects who lose less than 15 letters of visual acuity

  12 months

• The percentage of subjects who gain greater than or equal to 15 letters of visual acuity

  12 months

• Mean change in visual acuity

  12 months

Study Arms (1)

Intravitreal Aflibercept injection

OTHER

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).

Drug: Intravitreal Aflibercept injection

Interventions

Intravitreal Aflibercept injection 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.

Intravitreal Aflibercept injection

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 -

You may not qualify if:

• 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.

Sponsors & Collaborators

• Retina Research Institute, LLC: lead
• Valley Retina Institute: collaborator

Study Sites (3)

The Retina Institute

St Louis, Missouri, 63128, United States

Location

The Retina Institute

St Louis, Missouri, 63141, United States

Location

Valley Retina Institute

McAllen, Texas, 78503, United States

Location

Related Publications (1)

• 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.

  PMID: 26599244 DERIVED

MeSH Terms

Conditions

Macular Degeneration

Condition Hierarchy (Ancestors)

Retinal Degeneration; Retinal Diseases; Eye Diseases

Study Officials

• Gaurav K. Shah, MD

  The Retina Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Gaurav K. Shah, MD, Principal Investigator

Study Record Dates

• First Submitted: August 2, 2012
• First Posted: August 6, 2012
• Study Start: October 1, 2012
• Primary Completion: November 1, 2014
• Study Completion: December 1, 2017
• Last Updated: October 27, 2017

Record last verified: 2017-10

Locations

US (3)