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 @ 2:29 AM
Ignite Modification Date:
2025-12-25 @ 2:29 AM
NCT ID:
NCT03117634
Eligibility Criteria:
Inclusion Criteria Participant
1. Male or female study participants, age \>=45 years of age at the time of informed consent.
2. Best corrected ETDRS visual acuity score \<= 78 (ie 20/32 or worse)
3. Diagnosis of PCV based on ICGA
1. Presence of intra retinal or subretinal fluid/blood at the fovea as seen on OCT
2. Treatment naïve
4. Media clarity, pupillary dilation and individual cooperation sufficient for study procedure including fundus photography.
5. Able and willing to provide informed consent.
1.2. Exclusion Criteria Participant
1. Medical condition that, in the opinion of the investigator, would preclude participation in the study (e.g.unstable medical status including blood pressure, cardiovascular disease, and glycemic control).
2. Participation in an investigational trial within 30 days of enrolment which involves treatment with unapproved investigational drug
3. Known allergy to any component of the study drug.
4. Blood pressure \> 180/110 (systolic above 180 OR diastolic above 110 on repeated measurements). If blood pressure is brought below 180/110 by anti-hypertensive treatment, individual can become eligible.
5. Myocardial infarction, other acute cardiac event requiring hospitalization, stroke, transient ischemic attack, or treatment for acute congestive heart failure within 4 months prior to randomization.
6. Systemic anti-VEGF or pro-VEGF treatment within four months prior to randomization or anticipated use during the study.
Study Eye
1. Eye with intra retinal or subretinal fluid due to other causes than PCV
2. An ocular condition is present (other than PCV) that, in the opinion of the investigator, might affect intra or sub retinal fluid or alter visual acuity during the course of the study (e.g., diabetic macula edema (DME), vein occlusion, uveitis or other ocular inflammatory disease, neovascular glaucoma, etc.)
3. Substantial cataract that, in the opinion of the investigator, is likely to be decreasing visual acuity by more than three lines (i.e., cataract would be reducing acuity to worse than 20/40 if eye was otherwise normal).
4. Any intraocular surgery within 3 months of enrollment
5. Treatment with intra vitreal corticosteroids
6. History of retinal detachment or surgery for retinal detachment
7. History of vitrectomy
8. History of macular hole
9. Evidence of vitreomacular traction that may preclude resolution of macular edema \> 4 disc areas of intra/sub retinal hemorrhage
10. Aphakia
11. Exam evidence of external ocular infection, including conjunctivitis, chalazion, or significant blepharitis
Other Eye
1. Active intraocular inflammation
2. History of uveitis
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
45 Years
Maximum Age:
90 Years
Study:
NCT03117634
Study Brief:
Protocol Section:
NCT03117634