NCT01355692

CompletedPhase 2/3

Evaluation of the Effects of Selective Photocoagulation for ...

Lumenis Be Ltd.Source

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Other study identifiers

Sponsor study identifier

LUM.NOVUS SRT.01

Study Type

interventional

Actual enrollment (reported)

32

Locations

1 country

Sites

2

Timeline

Study Start

December 2009

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

June 2015

Actual (reported)

Study Completion

July 2015

Actual (reported)

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.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Actual enrollment (reported): 32 participants
Study completion date: July 2015
Actual (reported)
Listed locations: 1 countries · 2 sites

Trial Relationships

Click on a node to explore related trials.

Some registry-reported names shown below are not yet linked in this graph.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
December 2009
Date type not reported
This date has not been verified as actual or estimated.
First Submitted
May 15, 2011
Actual (reported)
First Posted
May 18, 2011
Actual (reported)
Primary Completion
June 2015
Actual (reported)
Study Completion
July 2015
Actual (reported)

Last Updated: September 7, 2016
Status Verified: September 2016
Last Update Submitted: September 6, 2016

Conditions

Diabetic Macular Edema

Keywords

DMELaserSelective laser therapyphotocoagulation

Outcome Measures

Primary Outcomes (1)

progression of macular edema
Proportion progressing to center involved macular edema by month 12 as confirmed on SD-OCT
12months

Study Arms (1)

Laser therapy

EXPERIMENTAL

Device: Nd: YLF laser treatment

Interventions

Nd: YLF laser treatmentDevice

grid selective retinal treatment

Also known as: SRT

Laser therapy

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

Sponsors & Collaborators

Lumenis Be Ltd.
Industrylead

Study Sites (2)

Tel Aviv Sourasky Medical Center

Tel Aviv, 64329, Israel

Sheba Medical Center

Tel Hahsomer, 52621, Israel

Study Officials

Anat Loewenstein, MD
Tel-Aviv Sourasky Medical Center
STUDY DIRECTOR
Joseph Moisseiev, Prof.
Sheba Medical Center
STUDY DIRECTOR

Enrollment

32 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 2 3
Allocation: NA
Masking: NONE
Purpose: TREATMENT
Intervention Model: SINGLE GROUP
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

May 15, 2011

First Posted

May 18, 2011

Study Start

December 2009

Date type not reported

This date has not been verified as actual or estimated.

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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.

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).

You may not qualify if:

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)

Contact the study team to confirm eligibility.

Primary Completion

June 2015

Actual (reported)

Study Completion

July 2015

Actual (reported)

Last Updated

September 7, 2016

Record last verified: 2016-09

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT01355692
Data provider: ClinicalTrials.gov
Source updated: 2016-09-07
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:20:59 UTC

Locations

IL(2)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Study Arms (1)

Laser therapy

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (2)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations