Safety Study of a Topical Treatment for Dry Age Related Macular Degeneration (NCT01922128) | Clinical Trial Compass
CompletedPhase 1
Safety Study of a Topical Treatment for Dry Age Related Macular Degeneration
United States20 participantsStarted 2013-09
Plain-language summary
Study to evaluate the safety and tolerability of MC-1101, a potential topical treatment for non-edxudative age Related Macular Degeneration (AMD) in medically stable individuals.
Who can participate
Age range
50 Years – 85 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Subjects ≥ 50 and ≤ 85 years of age.
. Women must be post-menopausal or surgically sterilized for 1 year or longer.
. Best corrected distance visual acuity of 1.0 logMAR of better in each eye (20/200 Snellen equivalent).
. Able and willing to sign informed consent and HIPAA authorization, follow study instructions and complete all study visits. A study visit may require several exams during the course of the day.
. Able and willing to discontinue the use of all ocular medication(s) except for artificial tears at least one week prior to receiving the study treatment and for the entire course of the study.
. General good health, as evaluated by the investigator, based on the medical history provided by the subject and any adjunctive testing carried out at the investigator's discretion.
Exclusion criteria
. Previous intravitreal injections of anti-VEGF therapies in either eye.
. History of diabetes and or diabetic retinopathy \> 10 years.
. Ocular of laser surgery in either eye within 3 months of Visit 1.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
No significant ocular or systemic adverse events in any of the 20 study subjects
. Ocular injection in either eye of any medication within 3 months of Visit 1.
. History of incisional glaucoma surgery in either eye.
. Corneal, cataract or media opacification in either eye which limits an adequate view of the fundus in the opinion of the investigator.
. Contraindications to pupil dilation in either eye.
. Any ocular disease that requires ongoing treatment with topical ocular agents in either eye during the study. Patients using intermittent ocular medications must stop these medications for one week prior to Visit 2. Use of artificial tears 3 times daily or less for mild dry eye disease is allowed, but must not occur within ± 15 minutes from dosing of the investigational product).