Safety Study of a Topical Treatment for Dry Age Related Macular Degeneration

NCT01922128 | Completed Phase 1 DMC

• 1 other identifier: MC-1101-002
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Nonexudative Age-related Macular Degeneration

Keywords

Non-exudative, dry AMD

Outcome Measures

Primary Outcomes (1)

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

  Assess the safety and tolerability of MC-1101 by evaluating the local ocular and systemic safety of MC-1101 0.5 % and 1 % in subjects in a dose escalation manner over 8 weeks of daily ocular exposure.

  56 total days

Study Arms (2)

Drug, MC-1101

ACTIVE COMPARATOR

One eye drop of Active comparator, 0.5% MC-1101, 2 times per day, 28 days; followed by one drop of 1% MC-1101, 2 times per day, 28 days.

Drug: MC-1101, Placebo

Placebo

PLACEBO COMPARATOR

One eye drop of Placebo comparator to MC-1101. Placebo contains all components of MC-1101 except for the active ingredient.

Drug: MC-1101, Placebo

Interventions

MC-1101, Placebo DRUG

One drop 0.5%; MC-1101; One drop 1.0% MC-1101, One drop Placebo

Drug, MC-1101; Placebo

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Ophthalmic:
• 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).
• Corneal disease, corneal irregularity or scarring that in the opinion of the investigator would make it difficult to accurately measure intraocular pressure (IOP) or visualize intraocular anatomy in either eye.
• Presence of a Hudson-Stahli line in the corneal epithelium in either eye.
• General/Systemic:
• Female subjects who are menstruating.
• Prior participation (participation is defined as being randomized to an investigational product) in any other study in the last 30 days.
• Subjects unable to administer or have a caretaker administer the study eye drops.

Sponsors & Collaborators

• MacuCLEAR, Inc.: lead

Study Sites (1)

Sall Eye Center

Artesia, California, 90701, United States

Location

Study Officials

• Ken Sall, MD

  Sall Eye Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 7, 2013
• First Posted: August 14, 2013
• Study Start: September 1, 2013
• Primary Completion: November 1, 2013
• Study Completion: December 1, 2013
• Last Updated: April 21, 2014

Record last verified: 2014-04

Locations

US (1)