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

• Sponsor: QLT Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01999764
• Collaborator: (none)
• Enrollment: 43
• Locations: 7
• Arms: 3
• Duration (Months): 8
• Patients Per Site: 6.1
• Patients Per Site Per Month: 0.8

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Impaired Dark Adaptation	Drug: QLT091001; Other: Placebo	Phase 2

Detailed Description

This proof-of-concept study is a randomized, parallel design of two different oral doses of QLT091001 compared to placebo to evaluate treatment effects in patients with impaired dark adaptation.

Approximately 40 subjects will be enrolled in this study at approximately 7 centers in the US.

Study Design

• Study Type: Interventional
• Actual Enrollment: 43 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: Evaluation of the Effects of Oral QLT091001 in Adults With Impaired Dark Adaptation
• Study Start Date: Nov 1, 2013
• Actual Primary Completion Date: Jun 1, 2014
• Actual Study Completion Date: Jul 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Placebo (for QLT091001) Placebo is supplied to mimic QLT091001 oral solution.	Other: Placebo; Placebo is administered orally at multiple time points.
Experimental: QLT091001 - first oral dose Subjects will receive an oral dose of 10mg/m2 of QLT091001.	Drug: QLT091001; QLT091001 administered orally at multiple time points.
Experimental: QLT091001 - second oral dose Subjects will receive an oral dose of 40 mg/m2 of QLT091001.	Drug: QLT091001; QLT091001 administered orally at multiple time points.

Outcome Measures

Primary Outcome Measures

1. Visual Acuity [Through 7 weeks]

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

Secondary Outcome Measures

1. Dark Adaptation Time [Through 7 weeks]

   Dark Adaptation Time will be measured at multiple time points.

Other Outcome Measures

1. Glare Recovery [Through 7 weeks]

   Glare recovery time will be measured at multiple time points.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 60 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Sall Research Medical Center	Artesia	California	United States	90701
2	California Retina Consultants	Santa Barbara	California	United States	93103
3	Ophthalmic Consultants of Boston	Boston	Massachusetts	United States	02114
4	Keystone Research Ltd.	Austin	Texas	United States	78731
5	Retina Foundation of the Southwest	Dallas	Texas	United States	75231
6	Retina Consultants of Houston	Houston	Texas	United States	77030
7	Proliance Surgeons Inc.	Seattle	Washington	United States	98004

Sponsors and Collaborators

• QLT Inc.

Investigators

• Study Director: Sushanta Mallick, Ph.D MBA, QLT Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: QLT Inc.
• ClinicalTrials.gov Identifier: NCT01999764
• Other Study ID Numbers: RET IDA 02
• First Posted: Dec 3, 2013
• Last Update Posted: Jul 14, 2015
• Last Verified: Jun 1, 2015

• Additional relevant MeSH terms: Retinol acetate

Study Results

No Results Posted as of Jul 14, 2015