Diabetic Macular EdemaPhase 2/3SRTNCT01355692
Evaluation of the Effects of Selective Photocoagulation for the Treatment of Diabetic Macular Edema
A Phase 2/3 study testing Nd: YLF laser treatment in people with Diabetic Macular Edema, run by Lumenis Be Ltd. at 2 sites in Israel.
Trial summary
The population of people suffering from diabetes is rapidly increasing, from an estimated 110 million in 1994 to 221 million in 2010. Diabetic macular edema is the most common reason for reduction in visual acuity in diabetic patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Macular Edema
- What is being tested?
- Nd: YLF laser treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 2 sitesIsrael
- Study dates
- Dec 2009to Jul 2015
- Phase
- Phase 2/3
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Best corrected ETDRS visual acuity letter score >=24 (app. 20/320 or better)
- Definite retinal thickness due to diabetic macular edema by on clinical exam at or within 500 to 3000 microns of the macular center (radius) for which the investigator believes laser photocoagulation is not indicated
- A thickness equal or less than 315 microns in the central subfield (confirmed by SD-OCT).
- A thickness of >2 SD of norm in one or more inner or outer subfields on SD-OCT.
- Maximal focal/grid laser not yet applied (within areas of thickening between 500 and 3000 microns from center of macula, not all microaneurysms treated with direct laser and not all other areas of thickening treated with grid laser). Maximal or complete laser treatment is defined as direct treatment to all microaneurysms within areas of edema and grid treatment to all other areas of macular edema.
- No panretinal scatter photocoagulation (PRP) within prior 4 months.
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- No recent medical treatment for DME (e.g., intravitreal/peribulbar steroids within past 4 months or intravitreal anti-VEGF injection within past 2 months).
- No major ocular surgery (including cataract extraction, any other intraocular surgery, scleral buckle, glaucoma filter, cornea transplant, etc.) within prior 6 months.
- No Nd:YAG laser capsulotomy within prior 2 months.
- Macular edema is not considered to be due to a cause other than diabetic macular edema
- o An eye should not be considered eligible (1) if the macular edema is considered to be related to cataract extraction or (2) clinical exam and/or SD-OCT suggests that vitreoretinal interface disease (eg. vitreoretinal traction or epiretinal membrane) is the primary cause of the macular edema.
- Media clarity, pupillary dilation, and patient cooperation sufficient for adequate fundus photos.
- No ocular condition (other than diabetes) that, in the opinion of the investigator, might affect macular edema or alter visual acuity during the first 12 months of the study (e.g., vein occlusion, uveitis or other ocular inflammatory disease, neovascular glaucoma, Irvine-Gass Syndrome).
- Glaucoma per se is not an exclusion
Who cannot join
- History of renal failure requiring dialysis or renal transplant
- Condition that in the opinion of the investigator would preclude participation in the study (e.g., unstable medical status including blood pressure and glycemic control)
- Patients in poor glycemic control who recently (>3 months) initiated intensive insulin treatment (a pump or multiple daily injections) or plan to do so in the next 3 months should not be enrolled.
- A patient with only one functioning eye (i.e., letter score 0 in contra-lateral eye)
Trial locations and contacts
2 sites in 1 country.
Israel2 sites
Tel Aviv Sourasky Medical Center
Tel Aviv, 64329
Sheba Medical Center
Tel Hahsomer, 52621
About this study
Official title: Phase III Multi Center Study Study of the Effects of Selective Retinal Photocoagulation for the Treatment of Diabetic Macular Edema
The population of people suffering from diabetes is rapidly increasing, from an estimated 110 million in 1994 to 221 million in 2010. Diabetic macular edema is the most common reason for reduction in visual acuity in diabetic patients.
The standard care for diabetic macular edema is focal and /or grid retinal photocoagulation. During photocoagulation, small laser burns are applied to the retina, the sensory tissue that lines the back of the eye. Studies have shown that photocoagulation of clinically significant diabetic macular edema substantially reduces the risk of visual loss, increase the chance of visual improvement and decrease the frequency of persistent macular edema. However, it remains unknown whether the destruction of sensory layer of the retina during photocoagulation that may cause visual field defects is necessary for successful treatment or is just an unwanted and unnecessary side effect.
Read more
Based on these concept, a photocoagulation technique was developed to treat the retina selectively (SRT - Selective retinal therapy), with minimal or no damage to the sensory layers. While the treatment is very similar to regular photocoagulation, the SRT laser uses much lower energy and very short pulses. As a result, treatment does not result in visible burns to the retina and previous studies have shown that the sensory layer remains intact.
The aim of this study is to determine the effect of SRT on the resolution of the edema.
- Conditions
- Diabetic Macular Edema
- Being tested
- Nd: YLF laser treatment
- Keywords
- DME, Laser, Selective laser therapy, photocoagulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nd: YLF laser treatmentDevice
Also called SRT
grid selective retinal treatment
| Study group | Role | What they receive |
|---|---|---|
| Laser therapy | Experimental | Not described Receives: Device: Nd: YLF laser treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
progression of macular edema
Proportion progressing to center involved macular edema by month 12 as confirmed on SD-OCT
Measured: 12months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2011 (estimated)
- Study startDec 2009
- Primary completionJun 2015
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Macular EdemaStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lumenis Be Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Anat Loewenstein, MD, Study director, Tel-Aviv Sourasky Medical CenterJoseph Moisseiev, Prof., Study director, Sheba Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01355692
- Sponsor's protocol ID
- LUM.NOVUS SRT.01
- Acronym
- SRT
- Status last verified
- Sep 2016
- First submitted
- 15 May 2011
- Last updated
- 7 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase III Multi Center Study Study of the Effects of Selective Retinal Photocoagulation for the Treatment of Diabetic Macular Edema
- ClinicalTrials.gov ID
- NCT01355692
- Acronym / sponsor ID
- SRT / LUM.NOVUS SRT.01
- Conditions
- Diabetic Macular Edema
- Keywords
- DME, Laser, Selective laser therapy, photocoagulation
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Lumenis Be Ltd.Industry (pharma, biotech, devices)
- Study start
- Dec 2009
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 18 May 2011 (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.
The population of people suffering from diabetes is rapidly increasing, from an estimated 110 million in 1994 to 221 million in 2010. Diabetic macular edema is the most common reason for reduction in visual acuity in diabetic patients.
The standard care for diabetic macular edema is focal and /or grid retinal photocoagulation. During photocoagulation, small laser burns are applied to the retina, the sensory tissue that lines the back of the eye. Studies have shown that photocoagulation of clinically significant diabetic macular edema substantially reduces the risk of visual loss, increase the chance of visual improvement and decrease the frequency of persistent macular edema. However, it remains unknown whether the destruction of sensory layer of the retina during photocoagulation that may cause visual field defects is necessary for successful treatment or is just an unwanted and unnecessary side effect.
Based on these concept, a photocoagulation technique was developed to treat the retina selectively (SRT - Selective retinal therapy), with minimal or no damage to the sensory layers. While the treatment is very similar to regular photocoagulation, the SRT laser uses much lower energy and very short pulses. As a result, treatment does not result in visible burns to the retina and previous studies have shown that the sensory layer remains intact.
The aim of this study is to determine the effect of SRT on the resolution of the edema.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Laser therapy | Experimental | Device: Nd: YLF laser treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Best corrected ETDRS visual acuity letter score >=24 (app. 20/320 or better)
- Definite retinal thickness due to diabetic macular edema by on clinical exam at or within 500 to 3000 microns of the macular center (radius) for which the investigator believes laser photocoagulation is not indicated
- A thickness equal or less than 315 microns in the central subfield (confirmed by SD-OCT).
- A thickness of >2 SD of norm in one or more inner or outer subfields on SD-OCT.
- Maximal focal/grid laser not yet applied (within areas of thickening between 500 and 3000 microns from center of macula, not all microaneurysms treated with direct laser and not all other areas of thickening treated with grid laser). Maximal or complete laser treatment is defined as direct treatment to all microaneurysms within areas of edema and grid treatment to all other areas of macular edema.
Key exclusion criteria (4 listed)
- History of renal failure requiring dialysis or renal transplant
- Condition that in the opinion of the investigator would preclude participation in the study (e.g., unstable medical status including blood pressure and glycemic control)
- Patients in poor glycemic control who recently (>3 months) initiated intensive insulin treatment (a pump or multiple daily injections) or plan to do so in the next 3 months should not be enrolled.
- A patient with only one functioning eye (i.e., letter score 0 in contra-lateral eye)
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 |
|---|---|---|
| Nd: YLF laser treatmentAlso: SRTgrid selective retinal treatment | Device | Laser therapy |
Primary outcome
progression of macular edema
Time frame: 12months
Proportion progressing to center involved macular edema by month 12 as confirmed on SD-OCT
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 7 Sep 2016.
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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.
Anat Loewenstein, MD study director
Tel-Aviv Sourasky Medical Center
Joseph Moisseiev, Prof. study director
Sheba Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Nd: YLF laser treatment in people with Diabetic Macular Edema, run by Lumenis Be Ltd. at 2 sites in Israel.
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 14 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: finished, as of the sponsor's last update on 7 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Israel. 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.
What does this combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
progression of macular edema (time frame: 12months). 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 7 Sep 2016.