DrusenNCT03968575
Sub-threshold Micro-Pulse Laser Therapy for Drusen of Dry AMD
A study testing laser treatment in people with Drusen, run by The Eye Hospital of Wenzhou Medical University at 1 site in China.
Trial summary
To investigate the efficacy and safety of sub-threshold micro-pulse laser therapy for drusen of dry age-related macular degeneration (AMD) . Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Drusen
- What is being tested?
- laser treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2019to 30 Apr 2022
- Phase
- Interventional
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Older than 50 years of age.
- Male or female patients with nonexudative AMD with a drusen diameter of at least 125um in the central 3mm circle
- 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 other macular disease such as epiretinal membrane, macular telangiectasia.
- unclear media that no clear colour, red-free imaging and fundus fluorescein angiography, fundus autofluorescence imaging and OCT can performed.
- Ocular or periocular infections.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The eye of Wenzhou Medical University
Wenzhou, Zhejiang, 325000
Ying Huang, 86-577-88068855, wzhuangying@163.com
Xiaoling Liu
About this study
Official title: The Affiliated Eye Hospital of Wenzhou Medical University
To investigate the efficacy and safety of sub-threshold micro-pulse laser therapy for drusen of dry age-related macular degeneration (AMD) .
- Conditions
- Drusen
- Being tested
- laser treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
laser treatmentDevice
sub-threshold micro-pulse laser treatment
| Study group | Role | What they receive |
|---|---|---|
| Laser | Experimental | Not described Receives: Device: laser treatment |
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 on optical coherence tomograph(OCT)
Measured: 6 and 12 months
Change in macular drusen area
Mean change in macular drusen area on OCT
Measured: 6 and 12 months
Secondary outcomes (1)
Change in visual acuity
Mean change in best-corrected visual acuity
Measured: 6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2019
- Study start1 Apr 2019
- Primary completion30 Apr 2021 (estimated)
- Study completion30 Apr 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DrusenStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Eye Hospital of Wenzhou Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiaoling Liu, The Eye Hospital of Wenzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03968575
- Sponsor's protocol ID
- 2019-075-K-74
- Status last verified
- Feb 2021
- First submitted
- 22 May 2019
- Last updated
- 24 Feb 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Affiliated Eye Hospital of Wenzhou Medical University
- ClinicalTrials.gov ID
- NCT03968575
- Acronym / sponsor ID
- 2019-075-K-74
- Conditions
- Drusen
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- The Eye Hospital of Wenzhou Medical UniversityUniversity, hospital or other
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- 30 Apr 2021 (estimated)
- Study completion
- 30 Apr 2022 (estimated)
- First posted
- 30 May 2019 (actual)
- 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.
To investigate the efficacy and safety of sub-threshold micro-pulse laser therapy for drusen of dry age-related macular degeneration (AMD) .
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Laser | Experimental | Device: laser treatment |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Older than 50 years of age.
- Male or female patients with nonexudative AMD with a drusen diameter of at least 125um in the central 3mm circle
- 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 (3 listed)
- Presence of other macular disease such as epiretinal membrane, macular telangiectasia.
- unclear media that no clear colour, red-free imaging and fundus fluorescein angiography, fundus autofluorescence imaging and OCT can performed.
- Ocular or periocular infections.
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 |
|---|---|---|
| laser treatmentsub-threshold micro-pulse laser treatment | Device | Laser |
Primary outcome
Change in macular drusen volume
Time frame: 6 and 12 months
Mean change in macular drusen volume on optical coherence tomograph(OCT)
Change in macular drusen area
Time frame: 6 and 12 months
Mean change in macular drusen area on OCT
1 secondary outcome
Change in visual acuity
Time frame: 6 and 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2021.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing laser treatment in people with Drusen, run by The Eye Hospital of Wenzhou Medical University at 1 site in China.
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 3 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: status not confirmed, as of the sponsor's last update on 24 Feb 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 China. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ying Huang (0577-88068855, wzhuangying@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in macular drusen volume (time frame: 6 and 12 months). The study lists 2 primary outcomes in all. 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 24 Feb 2021.