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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
University Hospital Schleswig-Holstein
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    October 13, 2009
    Last Updated
    January 15, 2013
    Sponsor
    University Hospital Schleswig-Holstein
    Collaborators
    Medical Laser Center Lübeck, Germany, St Thomas
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    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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