Impaired Dark AdaptationPhase 2NCT01999764
Evaluation of the Effects of Oral QLT091001 in Adults With Impaired Dark Adaptation
A Phase 2 study testing QLT091001 in people with Impaired Dark Adaptation, run by QLT Inc. at 7 sites in United States.
Trial summary
This is a Phase IIa proof-of-concept study to evaluate the effects of oral QLT091001 on adults with impaired dark adaptation. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Impaired Dark Adaptation
- What is being tested?
- QLT091001
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 43 participants
- Where
- 7 sitesUnited States
- Study dates
- Nov 2013to Jul 2014
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Sall Research Medical Center
Artesia, California, 90701
Keystone Research Ltd.
Austin, Texas, 78731
Ophthalmic Consultants of Boston
Boston, Massachusetts, 02114
Retina Foundation of the Southwest
Dallas, Texas, 75231
Retina Consultants of Houston
Houston, Texas, 77030
California Retina Consultants
Santa Barbara, California, 93103
Proliance Surgeons Inc.
Seattle, Washington, 98004
About this study
This is a Phase IIa proof-of-concept study to evaluate the effects of oral QLT091001 on adults with impaired dark adaptation.
Read the 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.
- Conditions
- Impaired Dark Adaptation
- Being tested
- QLT091001, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QLT091001Drug
QLT091001 administered orally at multiple time points.
PlaceboOther
Placebo is administered orally at multiple time points.
| Study group | Role | What they receive |
|---|---|---|
| Placebo (for QLT091001) | Placebo comparator | Placebo is supplied to mimic QLT091001 oral solution. Receives: Other: Placebo |
| QLT091001 - first oral dose | Experimental | Subjects will receive an oral dose of 10mg/m2 of QLT091001. Receives: Drug: QLT091001 |
| QLT091001 - second oral dose | Experimental | Subjects will receive an oral dose of 40 mg/m2 of QLT091001. Receives: Drug: QLT091001 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Acuity
Low luminance low contrast best-corrected visual acuity (LLLC BCVA) will be measured at multiple time points.
Measured: Through 7 weeks
Secondary outcomes (1)
Dark Adaptation Time
Dark Adaptation Time will be measured at multiple time points.
Measured: Through 7 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2013 (estimated)
- Study startNov 2013
- Primary completionJun 2014
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Impaired Dark AdaptationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- QLT Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sushanta Mallick, Ph.D MBA, Study director, QLT Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01999764
- Sponsor's protocol ID
- RET IDA 02
- Status last verified
- Jun 2015
- First submitted
- 25 Nov 2013
- Last updated
- 14 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effects of Oral QLT091001 in Adults With Impaired Dark Adaptation
- ClinicalTrials.gov ID
- NCT01999764
- Acronym / sponsor ID
- RET IDA 02
- Conditions
- Impaired Dark Adaptation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- QLT Inc.Industry (pharma, biotech, devices)
- Study start
- Nov 2013
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 3 Dec 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo (for QLT091001) | Placebo comparator | Other: PlaceboPlacebo is supplied to mimic QLT091001 oral solution. |
| QLT091001 - first oral dose | Experimental | Drug: QLT091001Subjects will receive an oral dose of 10mg/m2 of QLT091001. |
| QLT091001 - second oral dose | Experimental | Drug: QLT091001Subjects will receive an oral dose of 40 mg/m2 of QLT091001. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QLT091001QLT091001 administered orally at multiple time points. | Drug | QLT091001 - first oral dose, QLT091001 - second oral dose |
| PlaceboPlacebo is administered orally at multiple time points. | Other | Placebo (for QLT091001) |
Primary outcome
Visual Acuity
Time frame: Through 7 weeks
Low luminance low contrast best-corrected visual acuity (LLLC BCVA) will be measured at multiple time points.
1 secondary outcome
Dark Adaptation Time
Time frame: Through 7 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2015.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sushanta Mallick, Ph.D MBA study director
QLT Inc.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing QLT091001 in people with Impaired Dark Adaptation, run by QLT Inc. at 7 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Acuity (time frame: Through 7 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2015.