Overview

This trial is active, not recruiting.

Condition age related macular degeneration
Treatment intravitreal aflibercept injection
Phase phase 4
Sponsor Retina Research Institute, LLC
Collaborator Valley Retina Institute
Start date October 2012
End date November 2014
Trial size 22 participants
Trial identifier NCT01657669, GS-01-12

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).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(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).
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.

Primary Outcomes

Measure
Resolution time of intraretinal cysts and sub retinal fluid on OCT
time frame: 12 months

Secondary Outcomes

Measure
Mean change in OCT central foveal thickness
time frame: 12 months
The percentage of subjects with no fluid on OCT
time frame: 12 months
The percentage of subjects who lose less than 15 letters of visual acuity
time frame: 12 months
The percentage of subjects who gain greater than or equal to 15 letters of visual acuity
time frame: 12 months
Mean change in visual acuity
time frame: 12 months
Mean change in macular volume
time frame: 12 months
Quantitative change in area (microns) from baseline in choroidal neovascular lesion characteristics/size as measured by ICG/FA/Fundus photos
time frame: 12 months
Mean number of injections of 2.0 mg intravitreal aflibercept injection
time frame: 12 months

Eligibility Criteria

Male or female participants at least 50 years old.

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. -

Additional Information

Official title Short-term Clinical Effects of Intravitreal Aflibercept Injection 2.0mg as a Predictor of Long-term Results
Principal investigator Gaurav K. Shah, MD
Description 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.
Trial information was received from ClinicalTrials.gov and was last updated in July 2015.
Information provided to ClinicalTrials.gov by Retina Research Institute, LLC.