Age-Related Macular DegenerationSAVENCT02960828
"Stop Early Age-related Macular Degeneration (AMD) From Vision Loss Eternally" Study
A study testing Subthreshold Laser Photocoagulation, intravitreal Anti-VEGF injection and Subthreshold Laser in people with Age-Related Macular Degeneration and Retinal Drusen, run by Seoul National University Bundang Hospital at 1 site in South Korea.
Trial summary
This study aims to validate the efficacy and safety of subthreshold laser photocoagulation on high-risk macular drusen in early age-related macular degeneration which has a high risk of conversion to exudative AMD. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Age-Related Macular Degeneration, Retinal Drusen
- What is being tested?
- Subthreshold Laser Photocoagulation, intravitreal Anti-VEGF injection and Subthreshold Laser
- Type of treatment
- Injection or infusion, Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jan 2016to Dec 2020
- 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
- Drusen in both eyes examined under fundoscopy
- At least one of the eyes must have high-risk soft drusen
- BCVA below ETDRS 83 letters
- Patient with consent to participate
Who cannot join
- Prior diagnosis with choroidal neovascularization
- Exudative AMD in at least one eye
- If the patient has only one visually effective eye (last eye)
- Other macula or retinal diseases than age-related macular degeneration
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul National University Bundang Hospital
Seongnam, Gyunggi-do, 463-707
About this study
Official title: Focal Subthreshold Laser Treatment for Macular Drusen
This study aims to validate the efficacy and safety of subthreshold laser photocoagulation on high-risk macular drusen in early age-related macular degeneration which has a high risk of conversion to exudative AMD.
Read the detailed description
SAVE Study (Stop Early Age-related Macular Degeneration form Vision Loss Eternally)
- Conditions
- Age-Related Macular Degeneration, Retinal Drusen
- Being tested
- Subthreshold Laser Photocoagulation, intravitreal Anti-VEGF injection, Subthreshold Laser
- 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.
Subthreshold Laser PhotocoagulationProcedure or surgery
Selective Subthreshold Laser Photocoagulation is applied to the periphery of high-risk macular drusen
intravitreal Anti-VEGF injectionDrug
To prevent choroidal neovascularization, intravitreal Anti-VEGF injection is done on a 3 month interval up to 1 year.
Subthreshold LaserDevice
| Study group | Role | What they receive |
|---|---|---|
| Intervention-"Device:_Laser" | Experimental | * Subthreshold focal photocoagulation
* Intravitreal Anti-vascular endothelial growth factor (Anti-VEGF) injection Receives: Procedure: Subthreshold Laser Photocoagulation; Drug: intravitreal Anti-VEGF injection; Device: Subthreshold Laser |
| Control | No intervention | Contralateral eye |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in drusen size
Measured: 3 month interval
Secondary outcomes (5)
Best Corrected Visual Acuity (BCVA)
ETDRS and Snellen visual acuity measurement
Measured: 3 months interval
Change in drusen distribution
Measured: 3 month interval
Change in autofluorescence
Measured: 3 month interval
Choroidal Neovascularization
Measured: 3 months interval
Contrast Sensitivity
Contrast Sensitivity Test
Measured: 3 months interval
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2016 (estimated)
- Study startJan 2016
- Primary completionMay 2020 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Age-Related Macular DegenerationStudies of the same condition, open and under way.
- More trials run by Seoul National University Bundang HospitalThe 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
- None (open label)
- Enrolment
- 21 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Bundang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kyu Hyung Park, Seoul National University Bundang Hospital
- Investigators
- Kyu Hyung Park, M.D., Ph.D., Principal investigator, Seoul National University Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02960828
- Sponsor's protocol ID
- B-1508/312-004
- Acronym
- SAVE
- Status last verified
- Sep 2019
- First submitted
- 30 Jun 2016
- Last updated
- 19 Sep 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided: undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Focal Subthreshold Laser Treatment for Macular Drusen
- ClinicalTrials.gov ID
- NCT02960828
- Acronym / sponsor ID
- SAVE / B-1508/312-004
- Conditions
- Age-Related Macular Degeneration, Retinal Drusen
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 21 participants (estimated)
- Lead sponsor
- Seoul National University Bundang HospitalUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- May 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 10 Nov 2016 (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 study aims to validate the efficacy and safety of subthreshold laser photocoagulation on high-risk macular drusen in early age-related macular degeneration which has a high risk of conversion to exudative AMD.
Detailed description
SAVE Study (Stop Early Age-related Macular Degeneration form Vision Loss Eternally)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention-"Device:_Laser" | Experimental | Procedure: Subthreshold Laser Photocoagulation, Drug: intravitreal Anti-VEGF injection, Device: Subthreshold Laser* Subthreshold focal photocoagulation * Intravitreal Anti-vascular endothelial growth factor (Anti-VEGF) injection |
| Control | No intervention | –Contralateral eye |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Drusen in both eyes examined under fundoscopy
- At least one of the eyes must have high-risk soft drusen
- BCVA below ETDRS 83 letters
- Patient with consent to participate
Key exclusion criteria (4 listed)
- Prior diagnosis with choroidal neovascularization
- Exudative AMD in at least one eye
- If the patient has only one visually effective eye (last eye)
- Other macula or retinal diseases than age-related macular degeneration
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 |
|---|---|---|
| Subthreshold Laser PhotocoagulationSelective Subthreshold Laser Photocoagulation is applied to the periphery of high-risk macular drusen | Procedure or surgery | Intervention-"Device:_Laser" |
| intravitreal Anti-VEGF injectionTo prevent choroidal neovascularization, intravitreal Anti-VEGF injection is done on a 3 month interval up to 1 year. | Drug | Intervention-"Device:_Laser" |
| Subthreshold Laser | Device | Intervention-"Device:_Laser" |
Primary outcome
Change in drusen size
Time frame: 3 month interval
5 secondary outcomes
Best Corrected Visual Acuity (BCVA)
Time frame: 3 months interval
Change in drusen distribution
Time frame: 3 month interval
Change in autofluorescence
Time frame: 3 month interval
Choroidal Neovascularization
Time frame: 3 months interval
Contrast Sensitivity
Time frame: 3 months interval
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2019.
- Individual participant dataSharing planned: Undecided. undecided
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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.
Kyu Hyung Park, M.D., Ph.D. principal investigator
Seoul National University Bundang Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Subthreshold Laser Photocoagulation, intravitreal Anti-VEGF injection and Subthreshold Laser in people with Age-Related Macular Degeneration and Retinal Drusen, run by Seoul National University Bundang Hospital at 1 site in South Korea.
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 4 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 19 Sep 2019. 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 South Korea. 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?
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 drusen size (time frame: 3 month interval). 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 19 Sep 2019.