Evaluation of the Effects of Selective Photocoagulation for the Treatment of Diabetic Macular Edema (SRT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01355692
Recruitment Status : Completed
First Posted : May 18, 2011
Last Update Posted : September 7, 2016
Information provided by (Responsible Party):
Lumenis Ltd.

Brief 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.

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.

Condition or disease Intervention/treatment Phase
Diabetic Macular Edema Device: Nd: YLF laser treatment Phase 2 Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase III Multi Center Study Study of the Effects of Selective Retinal Photocoagulation for the Treatment of Diabetic Macular Edema
Study Start Date : December 2009
Actual Primary Completion Date : June 2015
Actual Study Completion Date : July 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Edema
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Laser therapy Device: Nd: YLF laser treatment
grid selective retinal treatment
Other Name: SRT

Primary Outcome Measures :
  1. progression of macular edema [ Time Frame: 12months ]
    Proportion progressing to center involved macular edema by month 12 as confirmed on SD-OCT

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Best corrected ETDRS visual acuity letter score >=24 (app. 20/320 or better)
  2. 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
  3. A thickness equal or less than 315 microns in the central subfield (confirmed by SD-OCT).
  4. A thickness of >2 SD of norm in one or more inner or outer subfields on SD-OCT.
  5. 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.
  6. No panretinal scatter photocoagulation (PRP) within prior 4 months.
  7. No recent medical treatment for DME (e.g., intravitreal/peribulbar steroids within past 4 months or intravitreal anti-VEGF injection within past 2 months).
  8. No major ocular surgery (including cataract extraction, any other intraocular surgery, scleral buckle, glaucoma filter, cornea transplant, etc.) within prior 6 months.
  9. No Nd:YAG laser capsulotomy within prior 2 months.
  10. 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.

  11. Media clarity, pupillary dilation, and patient cooperation sufficient for adequate fundus photos.
  12. 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

Exclusion Criteria:

  1. History of renal failure requiring dialysis or renal transplant
  2. 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)
  3. 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.
  4. A patient with only one functioning eye (i.e., letter score 0 in contra-lateral eye)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01355692

Tel Aviv Sourasky Medical Center
Tel Aviv, Israel, 64329
Sheba Medical Center
Tel Hahsomer, Israel, 52621
Sponsors and Collaborators
Lumenis Ltd.
Study Director: Anat Loewenstein, MD Tel-Aviv Sourasky Medical Center
Study Director: Joseph Moisseiev, Prof. Sheba Medical Center

Responsible Party: Lumenis Ltd. Identifier: NCT01355692     History of Changes
Other Study ID Numbers: LUM.NOVUS SRT.01
First Posted: May 18, 2011    Key Record Dates
Last Update Posted: September 7, 2016
Last Verified: September 2016

Keywords provided by Lumenis Ltd.:
Selective laser therapy

Additional relevant MeSH terms:
Macular Edema
Signs and Symptoms
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases