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

QLT Inc.

Status and phase: Completed; Phase 2

Conditions: Impaired Dark Adaptation

Treatments: Drug: QLT091001; Other: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01999764

RET IDA 02

Details and patient eligibility

About

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

Full 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.

Enrollment: 43 patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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43 participants in 3 patient groups, including a placebo group

Placebo (for QLT091001)

Placebo Comparator group

Description:

Placebo is supplied to mimic QLT091001 oral solution.

Treatment:

Other: Placebo

QLT091001 - first oral dose

Experimental group

Description:

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

Treatment:

Drug: QLT091001

QLT091001 - second oral dose

Experimental group

Description:

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

Treatment:

Drug: QLT091001