Overview

This trial is active, not recruiting.

Conditions choroidal neovascularization, presumed ocular histoplasmosis
Treatment eylea (aflibercept) intravitreal injection
Phase phase 1
Sponsor Retina Research Institute, LLC
Start date June 2012
End date April 2014
Trial size 5 participants
Trial identifier NCT01578720, KB-001

Summary

The purpose of this study is to assess the efficacy and safety of intravitreal injection of aflibercept for the treatment of Choroidal Neovascularization (CNV) secondary to presumed ocular histoplasmosis syndrome (POHS).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Other)
Intravitreal aflibercept injection 2.0mg dosed every 4 weeks (monthly)for the first 3 months followed by 2.0 mg (0.05mL) via intravitreal injection every eight 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 greater than or equal to 5 letters from the previous visit.
eylea (aflibercept) intravitreal injection
Intravitreal Injection once every 8 weeks with 3 initial monthly doses

Primary Outcomes

Measure
Safety
time frame: 12 months

Secondary Outcomes

Measure
Mean visual acuity (BCVA) at Months 6 and 12
time frame: Month 6 and Month 12
Mean change in OCT central foveal thickness from baseline at Months 6 and 12
time frame: Months 6 and 12
Mean change in Macular Volume from baseline at Months 6 and 12
time frame: Months 6 and 12
Mean change in visual acuity (BCVA) from baseline at Months 6 and 12
time frame: Months 6 and 12
Mean change in CNV lesion characteristics (size, leakage, etc.) from baseline at Months 6 and 12
time frame: Months 6 and 12
Proportion of patients with no fluid on OCT (absence of cystic edema and subretinal fluid) at Months 6 and 12
time frame: Months 6 and 12

Eligibility Criteria

Male or female participants at least 21 years old.

Inclusion Criteria: - CNV of less than 1 year duration due to presumed ocular histoplasmosis - Ability to provide written informed consent and comply with study assessments for the full duration of the study - Age 21 years and older - Subfoveal or juxtafoveal CNV lesion of less than 5400um in diameter - Best corrected visual acuity of 20/25 to 20/400 - Birth control therapy for females of child-bearing age Exclusion Criteria: - CNV due to presumed ocular histoplasmosis for greater than 1 year - 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 - A recent history of smoking (within 1 year of study enrollment) - Prior treatment with intravitreal aflibercept injection - Any other condition that the investigator believes would pose a significant hazard to the subject if the investigational therapy were initiated - Uncontrolled glaucoma in the study eye (defined as IOP greater 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 - Active infectious conjunctivitis, keratitis, scleritis, or endophthalmitis in either eye - Presence of significant subfoveal fibrosis or atrophy - Intraocular surgery (including cataract surgery) in the study eye within 2 months of enrollment - Active intraocular inflammation (grade trace or above) in the study eye - History of allergy to fluorescein, ICG or iodine, not amendable to treatment - Any concurrent intraocular condition in the study eye (e.g., cataract or diabetic retinopathy) that, in the opinion of the investigator, could either - Require medical or surgical intervention during the 12 month study period to prevent or treat visual loss that might result from that condition, or - If allowed to progress untreated, could likely contribute to loss of at least 2 snellen equivalent lines of BCVA over the 12 month study period - Prior/Concomitant Treatment: - Panretinal photocoagulation treatment - Previous intraocular steroids or PDT within 3 months - Previous participation in any studies of investigational drugs within 30 days preceding Day 0 (excluding vitamins and minerals) - Previous treatment with intravitreally (in either eye) or intravenously administered Avastin (bevacizumab) within 60 days - Previous use of Macugen or Lucentis in study eye within 60 days - Prior submacular or vitreous surgery

Additional Information

Official title Treatment of CNV Secondary to Presumed Ocular Histoplasmosis With EYLEA 2.0mg (Intravitreal Aflibercept Injection)
Principal investigator Kevin J Blinder, MD
Trial information was received from ClinicalTrials.gov and was last updated in July 2015.
Information provided to ClinicalTrials.gov by Retina Research Institute, LLC.