Treatment for Presumed Ocular Histoplasmosis

Ocular Histoplasmosis Clinical Trial

— HANDLE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01790893
• Other study ID #: IND 117497
• Status: Recruiting
• Phase: Phase 1/Phase 2
• First received: February 11, 2013
• Last updated: June 13, 2014
• Start date: March 2013
• Est. completion date: August 2014

Study information

• Verified date: June 2014
• Source: Retina Associates of Kentucky
• Contact: Diana Holcomb, COA
• Phone: 859-264-2905
• Email: dholcomb[@]retinaky.com
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: August 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Choroidal Neovascularization
• Histoplasmosis
• Ocular Histoplasmosis

Intervention

Drug:
• aflibercept

Locations

Country	Name	City	State
United States	Southeast Retina	Augusta	Georgia
United States	Cincinnati Eye Institute	Cincinnati	Ohio
United States	Retina Associates of Kentucky	Lexington	Kentucky

Sponsors (1)

Lead Sponsor	Collaborator
John Kitchens, MD

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	OCT changes	Mean change from baseline in central subfield thickness over time up to 12 months assessed on OCT	baseline to 12 months	Yes
Primary	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	Yes
Secondary	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	Months 3, 6, 9 and 12	Yes

External Links

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