Treatment for Presumed Ocular Histoplasmosis (HANDLE)
The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified June 2014 by Retina Associates of Kentucky.
Recruitment status was: Recruiting
Information provided by (Responsible Party):
John Kitchens, MD, Retina Associates of Kentucky
First received: February 11, 2013
Last updated: June 13, 2014
Last verified: June 2014
The purpose of this study is to monitor safety outcomes for patients being treated with intravitreal aflibercept injections for choroidal neovascularization secondary to Presumed Ocular Histoplasmosis Syndrome.
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
||Intravitreal Aflibercept Injection for the Treatment of cHoroidAl Neovascularization seconDary to Presumed ocuLar Histoplasmosis syndromE.(the HANDLE Study)
Primary Outcome Measures:
Secondary Outcome Measures:
- Visual acuity [ Time Frame: Months 3, 6, 9 and 12 ]
- Mean change in BCVA from Baseline
- Proportion of subjects gaining >5,10 and 15 letters
- Proportion of subjects losing >5, 10 and 15 letters
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||August 2014 (Final data collection date for primary outcome measure)
Experimental: intravitreal aflibercept injection
Group A -Monthly intravitreal aflibercept injection for 3 months (Baseline, Months 1 and 2), then mandatory every 2 months intravitreal aflibercept injection (Months 4,6, 8 and 10)for 12 months. Monthly visits with evaluations for as needed intravitreal aflibercept injection.
Experimental: intravitreal aflibercept
Group B- One intravitreal aflibercept injection at Baseline, then monthly visits with evaluations for as needed dosing of intravitreal aflibercept injection for 12 months.
|Ages Eligible for Study:
||18 Years and older (Adult, Senior)
|Sexes Eligible for Study:
|Accepts Healthy Volunteers:
- Active choroidal neovascularization (CNV) secondary to presumed ocular histoplasmosis demonstrated by active leakage on fluorescein angiography with spectal domain OCT evidence of subretinal or intraretinal fluid or PED.
- Active CNV may also be defined as demonstrating active subretinal hemorrhage.
- ETDRS Best corrected visual acuity 20/20-20/320.
- willing and able to comply with all study clinic visits and study related procedures.
- Willing to use and practice more than one form of contraceptives during the 13 month study for male and female.
- Provide signed informed consent
- Able to understand and complete study related questionnaires
- Under 18 years of age
- CNV due to other causes than Presumed Ocular Histoplasmosis
- Previous treatment in the study eye within 6 months prior to Day 1
- More than 5 Intravitreal injections of anti-VEGF therapy within previous 12 months
- Any clinical evidence of any other ocular condition other than Ocular histoplasmosis
- History of allergy to fluorescein
- Pregnant( or planning on becoming pregnant within the next 13 months) or breast feeding women
- Sexually Active Men or Women who are NOT willing to practice more than one form of contraceptives during the next 13 months.
- Anticipated or previous (within previous 3 months) systemic anti-VEGF therapy
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01790893
|Augusta, Georgia, United States, 30909 |
|Retina Associates of Kentucky
|Lexington, Kentucky, United States, 40509 |
|Cincinnati Eye Institute
|Cincinnati, Ohio, United States, 45242 |
John Kitchens, MD
||John W Kitchens, MD
||Retina Associates of Kentucky
||John Kitchens, MD, Sponsor-Investigator, Retina Associates of Kentucky
History of Changes
|Other Study ID Numbers:
|Study First Received:
||February 11, 2013
||June 13, 2014
Keywords provided by Retina Associates of Kentucky:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on February 20, 2017