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:
2025-12-24 @ 12:11 PM
Ignite Modification Date:
2025-12-24 @ 12:11 PM
NCT ID:
NCT01822561
Eligibility Criteria:
Inclusion Criteria:
1. Age 18 or over
2. Ability to give written informed consent
3. Presence of sub-retinal fluid under the fovea as seen on OCT
4. Diagnosis of Acute or Chronic CSCR:
* Acute CSCR: First presentation to eye clinic with visual symptoms, including decreased vision or visual distortion, and the characteristic appearance of CSCR on examination, fluorescein angiography, and OCT.
* Chronic CSCR: Previous diagnosis of CSCR, persistent subretinal fluid on OCT for more than 3 months after initial presentation to the eye clinic, and \<50% reduction in fluid thickness on OCT after 3 months. Patients who have had previous treatment for CSCR may be included.
Exclusion Criteria:
1. Age less than 18
2. Persons with impaired decision-making ability.
3. Women who are known to be pregnant or are actively trying to conceive.
4. Additional eye disease affecting the macula or posterior retina.
5. At screening, serum potassium concentration ≥5.0 mEq/L , a serum creatinine concentration \>2 mg/dL in men and \>1.8 mg/dL in women, or a creatinine clearance \<50 mL/min, and during concomitant administration of potassium supplements, potassium-sparing diuretics, and/or potent CYP3A4 inhibitors (amifostine, cyclosporine, fluconazole, itraconazole, ketoconazole, mifepristone, posaconazole, potassium salts, Rituximab, tacrolimus or voriconazole).
6. Patients with type 2 diabetes will be screened for microalbuminuria with a urinalysis. If microalbuminuria is present, these patients will be excluded.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT01822561
Study Brief:
Protocol Section:
NCT01822561