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 @ 10:37 PM
Ignite Modification Date:
2025-12-24 @ 10:37 PM
NCT ID:
NCT01527435
Eligibility Criteria:
Inclusion Criteria:
1. Male or female at least 50 years of age.
2. Subjects must have age related macular degeneration with a choroidal neovascular membrane either classic or occult in at least one eye.
3. Preoperative best corrected visual acuity (BCVA) equal to or greater to 19 letters on the ETDRS diabetic retinopathy study chart (20/400 Snellen).
4. Media clarity, pupillary dilation and subject cooperation sufficient for accurate OCT and angiographic assessment.
5. Written and informed consent has been obtained.
6. Written authorization for the use and release of the health and research study information in the United States of America USA.
7. Ability to understand the informed consent and willingness to follow study instruction and likely to complete all required visits and procedures.
Exclusion Criteria:
1. Evidence of diabetic retinopathy or other retinal disease other than age related macular degeneration.
2. Any severe active ocular disease or condition that in the opinion of the investigator is severe enough to prevent a 3 line improvement in visual acuity or to compromise the study results.
3. Any presumed ocular infections, i.e. bacterial, viral, parasitic, or fungal in either eye at the baseline visit.
4. Contraindication to pupillary dilation in either eye.
5. Uncontrolled systemic disease.
6. Any condition (including inability to read visual acuity charts and language barriers) which precludes subjects ability to comply with the study requirements including the completion of the study.
7. Subject has a condition or is in a situation which the investigator's opinion may put the subject at significant risk, may confound the study results or may interfere significantly with the subjects participation in the study.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
50 Years
Study:
NCT01527435
Study Brief:
Protocol Section:
NCT01527435