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 range50 Years – 85 Years

SexALL

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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.
✕. 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).

What they're measuring

No significant ocular or systemic adverse events in any of the 20 study subjects

Timeframe: 56 total days

Trial details

NCT IDNCT01922128

SponsorMacuCLEAR, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2013-11

View on ClinicalTrials.gov More Nonexudative Age-related Macular Degeneration trials