Evaluation of the Effects of Oral QLT091001 in Adults With Impaired Dark Adaptation

NCT01999764 | Completed Phase 2

• 1 other identifier: RET IDA 02
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 7

Brief Summary

This is a Phase IIa proof-of-concept study to evaluate the effects of oral QLT091001 on adults with impaired dark adaptation.

Conditions

Impaired Dark Adaptation

Outcome Measures

Primary Outcomes (1)

• Visual Acuity

  Low luminance low contrast best-corrected visual acuity (LLLC BCVA) will be measured at multiple time points.

  Through 7 weeks

Secondary Outcomes (1)

• Dark Adaptation Time

  Through 7 weeks

Other Outcomes (1)

• Glare Recovery

  Through 7 weeks

Study Arms (3)

Placebo (for QLT091001)

PLACEBO COMPARATOR

Placebo is supplied to mimic QLT091001 oral solution.

Other: Placebo

QLT091001 - first oral dose

EXPERIMENTAL

Subjects will receive an oral dose of 10mg/m2 of QLT091001.

Drug: QLT091001

QLT091001 - second oral dose

EXPERIMENTAL

Subjects will receive an oral dose of 40 mg/m2 of QLT091001.

Drug: QLT091001

Interventions

QLT091001 DRUG

QLT091001 administered orally at multiple time points.

QLT091001 - first oral dose; QLT091001 - second oral dose

Placebo OTHER

Placebo is administered orally at multiple time points.

Placebo (for QLT091001)

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female subjects ≥60 yrs with early age-related macular degeneration (AMD) based on LLLC BCVA criterion or evidence of impaired dark adaptation
• Subjects with high luminance high contrast best-corrected visual acuity (HLHC BCVA) of 40 letters (20/40 Snellen) or better in the study eye
• Capable and willing to provide consent

You may not qualify if:

• Women of child bearing potential
• Subjects with late AMD or any other optic neuropathy in the study eye
• Subjects with posterior subcapsular cataract or multifocal intra-ocular lens (IOL) in the study eye
• Subjects who are actively participating in an experimental therapy study or who have received experimental therapy within 60 days of Day 0 or who have taken any prescription/investigational oral retinoid medication within 6 months of Day 0
• Subjects taking age-related eye disease study (AREDS) supplements containing beta-carotene

Sponsors & Collaborators

• QLT Inc.: lead

Study Sites (7)

Sall Research Medical Center

Artesia, California, 90701, United States

Location

California Retina Consultants

Santa Barbara, California, 93103, United States

Location

Ophthalmic Consultants of Boston

Boston, Massachusetts, 02114, United States

Location

Keystone Research Ltd.

Austin, Texas, 78731, United States

Location

Retina Foundation of the Southwest

Dallas, Texas, 75231, United States

Location

Retina Consultants of Houston

Houston, Texas, 77030, United States

Location

Proliance Surgeons Inc.

Seattle, Washington, 98004, United States

Location

MeSH Terms

Interventions

retinol acetate

Study Officials

• Sushanta Mallick, Ph.D MBA

  QLT Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 25, 2013
• First Posted: December 3, 2013
• Study Start: November 1, 2013
• Primary Completion: June 1, 2014
• Study Completion: July 1, 2014
• Last Updated: July 14, 2015

Record last verified: 2015-06

Locations

US (7)