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 @ 2:36 AM
Ignite Modification Date:
2025-12-25 @ 2:36 AM
NCT ID:
NCT02749734
Eligibility Criteria:
Inclusion Criteria:
* Aging from 18 to 75 years
* must have signed informed consent
* At least one visually impaired eye caused by macular degeneration diseases
* Can not be effectively treated with conventional therapies
* Best corrected visual acuity scores between 19 and 73 letter in ETDRs (early treatment diabetic retinopathy ) eye chart , including 19 and 73 (or the equivalent of Snellen eyesight from 20/400 to 20/40)
* Visual loss caused by macular degeneration diseases
Exclusion Criteria:
* Eyes with concomitant diseases which will interfere the visual improvement of the study
* Active intraocular inflammation regardless of the grade of severity
* Active infection (e.g. conjunctivitis, keratitis, scleritis, uveitis, ophthalmia)
* History of uveitis
* Severe cataract, glaucoma, retinal blood vessels occlusion, retinal detachment, macular hole, vitreous-macula traction
* Iris neovascularization
* Patients who have only one functioning eye, or the best corrected vision of untreated eye scores less than 24 letters in ETDRS chart(corresponding to 20/320 in Snellen chart)
* History of intraocular surgery
* Severe systemic diseases: Stroke, coronary heart disease, angina pectoris, renal insufficiency needing dialysis
* Allergic to sodium fluorescein
* Uncontrolled hypertension (systolic pressure\>140mmHg,or diastolic pressure\>90mmHg)
* Coagulative function disorder
* System administration of drugs that are toxic to lens, retina, or optic nerve like hydroxychloroquine, phenothiazine, ethambutol, tamoxifen, etc.
* Involved in other clinical trials of any medicine within 1 month (or within 5 half-life periods)
* Have maternity plan in 6 months
* In pregnancy or lactation period.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT02749734
Study Brief:
Protocol Section:
NCT02749734