NCT01790893

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Mar 2013

Geographic Reach
1 country

3 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 11, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 13, 2013

Completed
16 days until next milestone

Study Start

First participant enrolled

March 1, 2013

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2014

Completed
Last Updated

June 16, 2014

Status Verified

June 1, 2014

Enrollment Period

1.4 years

First QC Date

February 11, 2013

Last Update Submit

June 13, 2014

Conditions

Ocular Histoplasmosis

Keywords

Histoplasmosis

Outcome Measures

Primary Outcomes (1)

  • 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

    through Month 12

Secondary Outcomes (1)

  • Visual acuity

    Months 3, 6, 9 and 12

Other Outcomes (1)

  • OCT changes

    baseline to 12 months

Study Arms (2)

intravitreal aflibercept injection

EXPERIMENTAL

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

intravitreal aflibercept

EXPERIMENTAL

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

Interventions

afliberceptDRUG
intravitreal afliberceptintravitreal aflibercept injection

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Southeast Retina

Augusta, Georgia, 30909, United States

RECRUITING

Retina Associates of Kentucky

Lexington, Kentucky, 40509, United States

RECRUITING

Cincinnati Eye Institute

Cincinnati, Ohio, 45242, United States

RECRUITING

Related Links

MeSH Terms

Conditions

Histoplasmosis

Interventions

aflibercept

Condition Hierarchy (Ancestors)

MycosesBacterial Infections and MycosesInfections

Study Officials

  • John W Kitchens, MD

    Retina Associates of Kentucky

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Diana Holcomb, COA

CONTACT

859-264-2905dholcomb@retinaky.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Sponsor-Investigator

Study Record Dates

First Submitted

February 11, 2013

First Posted

February 13, 2013

Study Start

March 1, 2013

Primary Completion

August 1, 2014

Study Completion

August 1, 2014

Last Updated

June 16, 2014

Record last verified: 2014-06

Locations

US(3)