Macular DegenerationNCT02569892
Non-Damaging Photothermal Therapy of Non-exudative Age Related Macular Degeneration
A study testing Pascal Retinal Laser Photocoagulator in people with Macular Degeneration and Retinal Drusen, run by Stanford University at 1 site in United States.
Trial summary
This is a randomized controlled study of non-damaging photothermal macular grid laser versus sham laser therapy in patients with dry age-related macular degeneration (AMD) and large high-risk drusen. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Macular Degeneration, Retinal Drusen
- What is being tested?
- Pascal Retinal Laser Photocoagulator
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2016to 25 Jan 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Older than 60 years of age.
- Male or female patients with nonexudative AMD with a drusen volume of of at least 0.03mm3 in the central 3mm circle
- Adequate pupil dilatation and clear media to perform colour, red-free imaging and fundus fluorescein angiography, fundus autofluorescence imaging and OCT.
- Able to give an informed consent.
Who cannot join
- Presence of signs of advanced AMD, such as CNV, haemorrhages or macular atrophy based on OCT and fundus autofluorescence photography (FAF).
- Previous macular laser treatment.
- Any previous ocular condition that may be associated with a risk of developing macular oedema.
- Vitreomacular traction determined clinically and /or by OCT, which in the opinion of the investigator, contributes to the macular oedema (associated or causing a detachment of the fovea).
- Presence of other macular disease such as epiretinal membrane, macular telangiectasia.
- Important known allergies to sodium fluorescein dye used in angiography.
Show all 9Show fewer
- Ocular or periocular infections.
- Planned intra-ocular surgery within one year.
- Patient is unavailable for follow-up visits.
Trial locations and contacts
1 site in 1 country.
United States1 site
Byers Eye Institute at Stanford University
Palo Alto, California, 94303
About this study
This is a randomized controlled study of non-damaging photothermal macular grid laser versus sham laser therapy in patients with dry age-related macular degeneration (AMD) and large high-risk drusen. The goal of the study is to determine if this treatment will reduce macular drusen volume and also whether this might improve visual acuity or reduce the risk of conversion to advanced age-related macular degeneration defined as development of choroidal neovascularization or geographic atrophy.
- Conditions
- Macular Degeneration, Retinal Drusen
- Being tested
- Pascal Retinal Laser Photocoagulator
- Medical subject headings
- Macular Degeneration, Retinal Drusen
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pascal Retinal Laser PhotocoagulatorDevice
Sub-threshold macular laser treatment with Pascal laser Endpoint Management System
| Study group | Role | What they receive |
|---|---|---|
| Laser Arm | Experimental | Participants receive treatment with sub-threshold macular laser photocoagulation Receives: Device: Pascal Retinal Laser Photocoagulator |
| Sham Laser Arm | Sham comparator | Participants receive sham treatment with sub-threshold macular laser photocoagulation (with power setting at zero) Receives: Device: Pascal Retinal Laser Photocoagulator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Macular Drusen Volume
Mean change in macular drusen volume as measured on high-resolution spectral domain ocular coherence tomography (SD-OCT)
Measured: baseline, 6, 12, and 24 months
Secondary outcomes (2)
Change in Visual Acuity
Mean change in best-corrected visual acuity as measured using early treatment diabetic retinopathy study (ETDRS) chart - average number of letters seen on chart
Measured: baseline, 6, 12, and 24 months
Development of Geographic Atrophy (GA) or Choroidal Neovascularization (CNV)
Count of eyes that develop geographic atrophy or choroidal neovascularization by 24 months.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2015 (estimated)
- Study start1 Sep 2016
- Primary completion1 Feb 2020
- Study completion25 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Macular DegenerationStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- Bascom Palmer Eye Institute
- Responsible party
- Principal investigator, Steven R. Sanislo, Stanford University
- Investigators
- Steven Sanislo, MD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02569892
- Sponsor's protocol ID
- IRB-33991
- Status last verified
- Oct 2021
- First submitted
- 5 Oct 2015
- Last updated
- 28 Oct 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-Damaging Photothermal Therapy of Non-exudative Age Related Macular Degeneration
- ClinicalTrials.gov ID
- NCT02569892
- Acronym / sponsor ID
- IRB-33991
- Conditions
- Macular Degeneration, Retinal Drusen
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- Bascom Palmer Eye Institute
- Study start
- 1 Sep 2016 (actual)
- Primary completion
- 1 Feb 2020 (actual)
- Study completion
- 25 Jan 2021 (actual)
- First posted
- 7 Oct 2015 (estimated)
- Results
- Posted 19 May 2021
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 randomized controlled study of non-damaging photothermal macular grid laser versus sham laser therapy in patients with dry age-related macular degeneration (AMD) and large high-risk drusen. The goal of the study is to determine if this treatment will reduce macular drusen volume and also whether this might improve visual acuity or reduce the risk of conversion to advanced age-related macular degeneration defined as development of choroidal neovascularization or geographic atrophy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Laser Arm | Experimental | Device: Pascal Retinal Laser PhotocoagulatorParticipants receive treatment with sub-threshold macular laser photocoagulation |
| Sham Laser Arm | Sham comparator | Device: Pascal Retinal Laser PhotocoagulatorParticipants receive sham treatment with sub-threshold macular laser photocoagulation (with power setting at zero) |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Older than 60 years of age.
- Male or female patients with nonexudative AMD with a drusen volume of of at least 0.03mm3 in the central 3mm circle
- Adequate pupil dilatation and clear media to perform colour, red-free imaging and fundus fluorescein angiography, fundus autofluorescence imaging and OCT.
- Able to give an informed consent.
Key exclusion criteria (9 listed)
- Presence of signs of advanced AMD, such as CNV, haemorrhages or macular atrophy based on OCT and fundus autofluorescence photography (FAF).
- Previous macular laser treatment.
- Any previous ocular condition that may be associated with a risk of developing macular oedema.
- Vitreomacular traction determined clinically and /or by OCT, which in the opinion of the investigator, contributes to the macular oedema (associated or causing a detachment of the fovea).
- Presence of other macular disease such as epiretinal membrane, macular telangiectasia.
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 |
|---|---|---|
| Pascal Retinal Laser PhotocoagulatorSub-threshold macular laser treatment with Pascal laser Endpoint Management System | Device | Laser Arm, Sham Laser Arm |
Primary outcome
Change in Macular Drusen Volume
Time frame: baseline, 6, 12, and 24 months
Mean change in macular drusen volume as measured on high-resolution spectral domain ocular coherence tomography (SD-OCT)
2 secondary outcomes
Change in Visual Acuity
Time frame: baseline, 6, 12, and 24 months
Development of Geographic Atrophy (GA) or Choroidal Neovascularization (CNV)
Time frame: 2 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Steven Sanislo, MD principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pascal Retinal Laser Photocoagulator in people with Macular Degeneration and Retinal Drusen, run by Stanford University at 1 site 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 4 inclusion and 9 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 28 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 May 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in Macular Drusen Volume (time frame: baseline, 6, 12, and 24 months). 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 28 Oct 2021.