Treatment for Presumed Ocular Histoplasmosis (HANDLE)

June 13, 2014 updated by: John Kitchens, MD

Intravitreal Aflibercept Injection for the Treatment of cHoroidAl Neovascularization seconDary to Presumed ocuLar Histoplasmosis syndromE.(the HANDLE Study)

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Georgia
      • Augusta, Georgia, United States, 30909
        • Recruiting
        • Southeast Retina
        • Contact:
        • Contact:
        • Principal Investigator:
          • Dennis Marcus, MD
        • Sub-Investigator:
          • Harinderjit Singh, MD
    • Kentucky
      • Lexington, Kentucky, United States, 40509
        • Recruiting
        • Retina Associates of Kentucky
        • Contact:
        • Principal Investigator:
          • John W. Kitchens, MD
        • Sub-Investigator:
          • William J Wood, MD
        • Sub-Investigator:
          • Tom Stone, MD
        • Sub-Investigator:
          • Rick Isernhagen, MD
        • Sub-Investigator:
          • Andrew Moshfeghi, MD
    • Ohio
      • Cincinnati, Ohio, United States, 45242
        • Recruiting
        • Cincinnati Eye Institute
        • Contact:
          • Megan Kingdon
          • Phone Number: 513-569-3669
        • Principal Investigator:
          • Daniel Miller, MD
        • Sub-Investigator:
          • Michael Petersen, MD, PhD
        • Sub-Investigator:
          • Robert Sisk, MD
        • Sub-Investigator:
          • Robert Foster, MD
        • Sub-Investigator:
          • Christopher Riemann, MD
        • Sub-Investigator:
          • Brian Toussaint, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

.
Drug: aflibercept
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.
Drug: aflibercept

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ocular and systemic adverse events
Time Frame: through Month 12
The primary objective of the study is the incidence and severity of ocular and systemic adverse events through Month 12
through Month 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Months 3, 6, 9 and 12

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
OCT changes
Time Frame: baseline to 12 months
Mean change from baseline in central subfield thickness over time up to 12 months assessed on OCT
baseline to 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

John Kitchens, MD

Investigators

  • Principal Investigator: John W Kitchens, MD, Retina Associates of Kentucky

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2013

Primary Completion (Anticipated)

August 1, 2014

Study Completion (Anticipated)

August 1, 2014

Study Registration Dates

First Submitted

February 11, 2013

First Submitted That Met QC Criteria

February 11, 2013

First Posted (Estimate)

February 13, 2013

Study Record Updates

Last Update Posted (Estimate)

June 16, 2014

Last Update Submitted That Met QC Criteria

June 13, 2014

Last Verified

June 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IND 117497

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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