Treatment for Presumed Ocular Histoplasmosis (HANDLE)
Primary Purpose
Ocular Histoplasmosis
Status
Unknown status
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
aflibercept
Sponsored by
About this trial
This is an interventional treatment trial for Ocular Histoplasmosis focused on measuring Histoplasmosis
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
- Southeast RetinaRecruiting
- Retina Associates of KentuckyRecruiting
- Cincinnati Eye InstituteRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
intravitreal aflibercept injection
intravitreal aflibercept
Arm Description
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. .
Group B- One intravitreal aflibercept injection at Baseline, then monthly visits with evaluations for as needed dosing of intravitreal aflibercept injection for 12 months.
Outcomes
Primary Outcome Measures
ocular and systemic adverse events
The primary objective of the study is the incidence and severity of ocular and systemic adverse events through Month 12
Secondary Outcome Measures
Visual acuity
Mean change in BCVA from Baseline
Proportion of subjects gaining >5,10 and 15 letters
Proportion of subjects losing >5, 10 and 15 letters
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01790893
Brief Title
Treatment for Presumed Ocular Histoplasmosis
Acronym
HANDLE
Official Title
Intravitreal Aflibercept Injection for the Treatment of cHoroidAl Neovascularization seconDary to Presumed ocuLar Histoplasmosis syndromE.(the HANDLE Study)
Study Type
Interventional
2. Study Status
Record Verification Date
June 2014
Overall Recruitment Status
Unknown status
Study Start Date
March 2013 (undefined)
Primary Completion Date
August 2014 (Anticipated)
Study Completion Date
August 2014 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
John Kitchens, MD
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ocular Histoplasmosis
Keywords
Histoplasmosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
intravitreal aflibercept injection
Arm Type
Experimental
Arm Description
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.
.
Arm Title
intravitreal aflibercept
Arm Type
Experimental
Arm Description
Group B- One intravitreal aflibercept injection at Baseline, then monthly visits with evaluations for as needed dosing of intravitreal aflibercept injection for 12 months.
Intervention Type
Drug
Intervention Name(s)
aflibercept
Primary Outcome Measure Information:
Title
ocular and systemic adverse events
Description
The primary objective of the study is the incidence and severity of ocular and systemic adverse events through Month 12
Time Frame
through Month 12
Secondary Outcome Measure Information:
Title
Visual acuity
Description
Mean change in BCVA from Baseline
Proportion of subjects gaining >5,10 and 15 letters
Proportion of subjects losing >5, 10 and 15 letters
Time Frame
Months 3, 6, 9 and 12
Other Pre-specified Outcome Measures:
Title
OCT changes
Description
Mean change from baseline in central subfield thickness over time up to 12 months assessed on OCT
Time Frame
baseline to 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Diana Holcomb, COA
Phone
859-264-2905
Email
dholcomb@retinaky.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John W Kitchens, MD
Organizational Affiliation
Retina Associates of Kentucky
Official's Role
Principal Investigator
Facility Information:
Facility Name
Southeast Retina
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30909
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jared Gardner
Phone
706-650-0061
Email
jgardner@southeastretina.com
First Name & Middle Initial & Last Name & Degree
Courtney Caulder
Phone
706-650-0061
Email
ccaulder@southeastretina.com
First Name & Middle Initial & Last Name & Degree
Dennis Marcus, MD
First Name & Middle Initial & Last Name & Degree
Harinderjit Singh, MD
Facility Name
Retina Associates of Kentucky
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40509
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Diana Holcomb
Phone
859-264-2905
Email
dholcomb@retinaky.com
First Name & Middle Initial & Last Name & Degree
John W. Kitchens, MD
First Name & Middle Initial & Last Name & Degree
William J Wood, MD
First Name & Middle Initial & Last Name & Degree
Tom Stone, MD
First Name & Middle Initial & Last Name & Degree
Rick Isernhagen, MD
First Name & Middle Initial & Last Name & Degree
Andrew Moshfeghi, MD
Facility Name
Cincinnati Eye Institute
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45242
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Megan Kingdon
Phone
513-569-3669
First Name & Middle Initial & Last Name & Degree
Daniel Miller, MD
First Name & Middle Initial & Last Name & Degree
Michael Petersen, MD, PhD
First Name & Middle Initial & Last Name & Degree
Robert Sisk, MD
First Name & Middle Initial & Last Name & Degree
Robert Foster, MD
First Name & Middle Initial & Last Name & Degree
Christopher Riemann, MD
First Name & Middle Initial & Last Name & Degree
Brian Toussaint, MD
12. IPD Sharing Statement
Links:
URL
http://www.retinaky.com
Description
Related Info
Learn more about this trial
Treatment for Presumed Ocular Histoplasmosis
We'll reach out to this number within 24 hrs