Evaluation of the Effects of Oral QLT091001 in Adults Wit... | NCT01999764

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

NCT01999764

Sponsor

QLT Inc.

Status

Completed

Last Update Posted

Jul 14, 2015Estimated

Enrollment

43Actual

Phase

Phase 2

Conditions

Impaired Dark Adaptation

Interventions

QLT091001
Placebo

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2013

Primary Completion Date

Jun 2014Actual

Completion Date

Jul 2014Actual

First Submitted Date

Nov 25, 2013

First Submission Date that Met QC Criteria

Nov 25, 2013

First Posted Date

Dec 3, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Jun 16, 2015

Certification/Extension First Submitted that Passed QC Review

Jun 16, 2015

Certification/Extension First Posted Date

Jul 14, 2015Estimated

Last Update Submitted Date

Jun 16, 2015

Last Update Posted Date

Jul 14, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

43Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
QLT091001	Drug	QLT091001 administered orally at multiple time points.	QLT091001 - first oral dose QLT091001 - second oral dose

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Visual Acuity	Low luminance low contrast best-corrected visual acuity (LLLC BCVA) will be measured at multiple time points.	Through 7 weeks

Secondary Outcomes

Measure	Description	Time Frame
Dark Adaptation Time	Dark Adaptation Time will be measured at multiple time points.	Through 7 weeks

Other Outcomes

Measure	Description	Time Frame
Glare Recovery	Glare recovery time will be measured at multiple time points.	Through 7 weeks

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

60 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Sushanta Mallick, Ph.D MBA	QLT Inc.	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Sall Research Medical Center		Artesia	California	90701	United States
California Retina Consultants