Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:11 AM
Ignite Modification Date:
2025-12-25 @ 1:11 AM
NCT ID:
NCT01790893
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
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01790893
Study Brief:
Protocol Section:
NCT01790893