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Non-damaging Retinal Laser Therapy With PASCAL Laser for Macular Diseases (EPM)

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.
 
ClinicalTrials.gov Identifier: NCT01975103
Recruitment Status : Unknown
Verified November 2018 by Daniel Lavinsky, Federal University of Rio Grande do Sul.
Recruitment status was:  Recruiting
First Posted : November 3, 2013
Last Update Posted : November 14, 2018
Sponsor:
Information provided by (Responsible Party):
Daniel Lavinsky, Federal University of Rio Grande do Sul

Tracking Information
First Submitted Date  ICMJE October 28, 2013
First Posted Date  ICMJE November 3, 2013
Last Update Posted Date November 14, 2018
Study Start Date  ICMJE March 2013
Estimated Primary Completion Date April 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 28, 2013)
Best corrected visual acuity [ Time Frame: 6 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 28, 2013)
Central macular thickness on OCT [ Time Frame: 6 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Non-damaging Retinal Laser Therapy With PASCAL Laser for Macular Diseases
Official Title  ICMJE Phase 2 Study of Non-damaging Retinal Laser Therapy Using PASCAL Laser With Endpoint Management Software for Macular Diseases
Brief Summary This trial seeks to prove the safety and efficacy of photothermal stimulation treatment to diabetic macular edema, chronic central serous retinopathy, macular edema secondary to branch retinal vein occlusion and macular telangiectasia.
Detailed Description Sub-visible, non-damaging photothermal stimulation (532nm) exposures of 100 ms in duration resulted in enhanced expression of heat shock proteins in the retina. To test clinical efficacy of sub-visible retinal therapy using ms-range exposures of visible lasers one needs first to establish proper titration methods necessary to assure on one hand the lack of tissue damage, and on the other hand sufficient hyperthermia to elicit cellular response. We used an algorithm based on computational and experimental data to provide parameters that can cause photothermal stimulation to the retinal pigment epithelium without causing collateral damage to photoreceptors or choroid. This method will be used to treat macular diseases such as diabetic macular edema, branch retinal vein occlusion macular edema, chronic central serous retinopathy and macular telangiectasia.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Masking Description:
One arm receives laser treatment and second arm received powerless laser treatment as a Sham group.
Primary Purpose: Treatment
Condition  ICMJE
  • Diabetic Macular Edema
  • Branch Retinal Vein Occlusion
  • Chronic Central Serous Retinopathy
  • Macular Telangiectasia
Intervention  ICMJE Procedure: Topcon Endpoint Management
Study Arms  ICMJE
  • Experimental: Topcon Endpoint management
    Active laser treatment
    Intervention: Procedure: Topcon Endpoint Management
  • Sham Comparator: Control
    Powerless (sham) laser treatment
    Intervention: Procedure: Topcon Endpoint Management
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: May 1, 2017)
20
Original Enrollment  ICMJE Not Provided
Estimated Study Completion Date  ICMJE April 2020
Estimated Primary Completion Date April 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • The patient must have macular edema involving the center of the macula with a corresponding leakage on fluorescein angiography.

Thickening of the fovea of at least 300 microns (thickness of the central point in OCT) with a standard deviation of the center point <10% and signal strength of ≥ 5 OCT ILM and borders (internal limiting membrane) and RPE (retinal pigment epithelium) properly identified. Also, the initial OCT must be confirmed by repeated measurements on the same day, with the thickness of the central point being within 10% between measurements. In cases where the OCT imaging program can not properly define the limits of ILM and RPE, if the investigator can obtain an estimate of the thickness of the manual by OCT central point of at least 300 microns, the patient will be considered eligible.

The distance visual acuity in the better eye corrected the study must have an index between 70 and 35 letters inclusive (Snellen equivalent of 20/40 to 20/200).

Clear media and eye pupil dilation adequate to allow fundus photography with good quality.

Intraocular pressure not exceeding 21 mmHg. The ophthalmologist should feel comfortable with the delay of the focal laser treatment (direct and grid, as needed) by at least 12 weeks in the study eye.

Patients with diabetes Type I or Type II as defined by WHO criteria of any gender and age ≥ 18 years.

Ability to provide a written consent. Ability to return for all study visits.

Exclusion Criteria:

  • Eyes with scatter photocoagulation (PRP) one month prior the enrollment, or eyes where scatter photocoagulation is required now, or it likely to be needed over the next 6months (for example, eyes with high risk PDR DRS not properly treated with photocoagulation).

Presence of any abnormality that is likely to confound the assessment of the improvement in visual acuity in eyes with macular edema to resolve or improve as an area of hard exudates involving the foveal avascular zone (FAZ - involving 2 or more quadrants centered around the foveal avascular zone), epiretinal membrane associated with signs of contraction and / or significant opacification (ie, striations within the diameter of a disc from the center of the fovea), or the presence of chorioretinal atrophy involving the center of the macula.

Vitreomacular traction determined clinically and / or OCT, which in the opinion of the investigator, contributes to macular edema (associated or cause a detachment of the fovea) and prevents the improvement with treatment.

Atrophy / scar / fibrosis involving the center of the macula, including evidence of atrophy treated with laser within 200 microns of the FAZ.

Patients who received panphotocoagulation, YAG laser, or peripheral retinal cryoablation (for retinal tears) or focal or grid photocoagulation within the last 12 weeks or more of treatment with focal or grid laser.

Significant opacities of the optical medium, including cataracts, which may interfere with visual acuity, assessment of toxicity or photography background. Patients will not be included if they have high probability of requiring cataract surgery within the next year.

Any intraocular surgery within 6 months prior to study entry. Prior peeling of epiretinal membrane or inner limiting membrane. Any major surgical procedure within one month of study entry Prior irradiation of the head region of the eye under study. Any previous pharmacological treatment for DME, BRVO, CSR or MacTel (including corticosteroid intravitreal, subconjunctival or subtenon) or at any time during the last 90 days for any other condition.

Important known allergies to sodium fluorescein dye used in angiography. Acute ocular or periocular infection.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 100 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Brazil
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01975103
Other Study ID Numbers  ICMJE EPM-001
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Daniel Lavinsky, Federal University of Rio Grande do Sul
Study Sponsor  ICMJE Federal University of Rio Grande do Sul
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Daniel Lavinsky, MD, PhD Federal University of Rio Grande do Sul
PRS Account Federal University of Rio Grande do Sul
Verification Date November 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP