Selective Retina Therapy (SRT) for Clinically Significant Diabetic Macular Edema
Primary Purpose
Diabetic Macular Edema
Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
selective retina therapy (SRT)
Sponsored by
About this trial
This is an interventional treatment trial for Diabetic Macular Edema focused on measuring SRT, laser, diabetic macular edema, diabetes, Clinically significant diabetic macular edema
Eligibility Criteria
Inclusion Criteria:
- Minimum age of 18 years and the presence of clinically significant DME according to the criteria of the ETDRS study
Exclusion Criteria:
- Ischemic diabetic macular edema, significant media opacity compromising the interpretation of fluorescein angiography and fundus photography, previous intraocular surgery, previous macular laser treatment, other retinal or ocular diseases, and known allergic hypersensitivity to fluorescein, indocyanine green, or iodine. General exclusion criteria included pregnancy or breast-feeding and significant medical conditions such as renal failure.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
selective retina therapy (SRT)
Arm Description
Focal laser treatment with an SRT-Laser which selectively affects the retinal pigment epithelium while sparing the photoreceptor layer.
Outcomes
Primary Outcome Measures
best-corrected visual acuity
Secondary Outcome Measures
change of retinal thickness, presence of hard exudates and leakage in FFA, specificity and sensitivity of optoacoustic measurements
Full Information
NCT ID
NCT00994955
First Posted
October 13, 2009
Last Updated
January 15, 2013
Sponsor
University Hospital Schleswig-Holstein
Collaborators
Medical Laser Center Lübeck, Germany, St Thomas
1. Study Identification
Unique Protocol Identification Number
NCT00994955
Brief Title
Selective Retina Therapy (SRT) for Clinically Significant Diabetic Macular Edema
Official Title
Selective Retina Therapy (SRT) for Clinically Significant Diabetic Macular
Study Type
Interventional
2. Study Status
Record Verification Date
January 2013
Overall Recruitment Status
Completed
Study Start Date
January 2006 (undefined)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
October 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital Schleswig-Holstein
Collaborators
Medical Laser Center Lübeck, Germany, St Thomas
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Selective Retina Therapy (SRT) is an effective and safe laser treatment of clinically significant diabetic macular edema which targets the retinal pigment epithelium while sparing the neurosensory retina.
Detailed Description
Abstract:
OBJECTIVE: To evaluate effectivity and safety of Selective Retina Therapy (SRT) for diabetic macular edema (DME).
DESIGN: Prospective two-center interventional uncontrolled case series. PARTICIPANTS: 39 eyes of 39 patients with previously untreated non-ischemic DME.
INTERVENTION: Focal laser treatment with an SRT-Laser which selectively affects the retinal pigment epithelium while sparing the photoreceptor layer. The pulse energy was individually adjusted to achieve angiographically visible but funduscopically invisible effects. Optoacoustic measurements were performed to detect the individual threshold of RPE damage during laser treatment and correlated with funduscopy and fundus fluorescein angiography (FFA) or indocyanine green angiography. Follow-up at 3 and 6 months post treatment included best-corrected ETDRS visual acuity (BCVA), FFA, fundus photography, and retinal thickness measured by optical coherence tomography (OCT).
MAIN OUTCOME MEASURES: Change of BCVA, change of retinal thickness, presence of hard exudates and leakage in FFA, specificity and sensitivity of optoacoustic measurements.
RESULTS: Mean BCVA improved from 43.7 letters (standard deviation, SD=9.1) at baseline to 46.1 letters (SD=10.5) at 6 months follow-up (p=0.02). BCVA improved (> 5 letters) or remained stable (+/- 5 letters) in 84% of eyes. 13% of eyes improved by ≥ 10 letters while 16% of eyes lost more than 5 letters. There was no severe loss of vision (loss of ≥ 15 letters). Overall, mean central retinal thickness, hard exsudates and leakage in FFA did not change significantly (p>0.05) while improvement of BCVA correlated with a reduction of hard exsudates and central retinal thickness. Specificity and sensitivity of detecting the angiographic visible threshold of RPE damage by optoacoustic measurements were 86% and 70%, respectively. No adverse effects or pain were noted during or after treatment.
CONCLUSION: SRT is an effective and safe treatment of DME with functional and anatomical improvement or stabilization in most patients. Optoacoustic measurements are suitable to detect the individual threshold of RPE damage.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Macular Edema
Keywords
SRT, laser, diabetic macular edema, diabetes, Clinically significant diabetic macular edema
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
Outcomes Assessor
Allocation
N/A
Enrollment
39 (Actual)
8. Arms, Groups, and Interventions
Arm Title
selective retina therapy (SRT)
Arm Type
Experimental
Arm Description
Focal laser treatment with an SRT-Laser which selectively affects the retinal pigment epithelium while sparing the photoreceptor layer.
Intervention Type
Device
Intervention Name(s)
selective retina therapy (SRT)
Intervention Description
laser treatment
Primary Outcome Measure Information:
Title
best-corrected visual acuity
Time Frame
2 years
Secondary Outcome Measure Information:
Title
change of retinal thickness, presence of hard exudates and leakage in FFA, specificity and sensitivity of optoacoustic measurements
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Minimum age of 18 years and the presence of clinically significant DME according to the criteria of the ETDRS study
Exclusion Criteria:
Ischemic diabetic macular edema, significant media opacity compromising the interpretation of fluorescein angiography and fundus photography, previous intraocular surgery, previous macular laser treatment, other retinal or ocular diseases, and known allergic hypersensitivity to fluorescein, indocyanine green, or iodine. General exclusion criteria included pregnancy or breast-feeding and significant medical conditions such as renal failure.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jost Hillenkamp, MD
Organizational Affiliation
Dept. of Ophthalmology, University Medical Center Schleswig-Holstein, Kiel Campus
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Selective Retina Therapy (SRT) for Clinically Significant Diabetic Macular Edema
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