Recruiting
Phase 1
Phase 2

Ranibizumab

Sponsor:

Retina Associates of Kentucky

Code:

NCT00955630

Conditions

Ocular Histoplasmosis Syndrome

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

ranibizumab

ranibizumab

Study Details

Brief summary:

The purpose of this study is to evaluate the safety and effectiveness of intravitreal ranibizumab (Lucentis) in patients with fluid and blood leakage in their eyes due to ocular histoplasmosis.

Conditions

Ocular Histoplasmosis Syndrome

Study ID

NCT00955630

Start date

Aug, 2009

Status verified date

Aug, 2009

Primary completion date

Aug, 2010

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • age 18 or over
  • active choroidal neovascularization secondary to ocular histoplasmosis
  • Visual acuity between 20/25 and 20/400

Exclusion Criteria:

  • pregnancy or intent to become pregnant within the next 12 months
  • nursing an infant
  • premenopausal women not using contraception
  • prior treatment with subfoveal thermal laser
  • allergy to sodium fluorescein simultaneous participation in another investigation or trial

Study Design

Enrollment

20 participants

Anticipated

Allocation

Randomized

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Monthly injections

3 monthly injections of ranibizumab followed by prn injections

active comparator: PRN injections

injections of ranibizumab on a prn basis from the start of the study

Interventions

ranibizumab

3 monthly injections of ranibizumab followed by prn injections for the remainder of the study

ranibizumab

prn injections of ranibizumab throughout the study

Primary outcome measure

  • incidence and severity of ocular adverse events as identified by eye examination [ Time Frame: 1 year ]
  • incidence and severity of other adverse events as identified by physical examination, subject reporting, and changes in vital signs [ Time Frame: 12 mos ]

Central Contacts and Locations

Central contacts

Diana Holcomb, COA

859-263-3900dholcomb@retinaky.com

Wanda Heath, BS, COT, CCRC

859-263-3900wheath@retinaky.com

Locations

Retina Associates of Kentucky

Recruiting

Lexington, Kentucky, United States, 40509

Principal Investigator:

John Kitchens, MD

More Information

Sponsor

Retina Associates of Kentucky

Last update posted

Aug 10, 2009

Last verified

Aug, 2009

Keywords

  • Histoplasmosis
  • Lucentis
  • Ranibizumab
  • OHS

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Retina Associates of Kentucky on 2009-08-10.