Non-damaging Retinal Laser Therapy With PASCAL Laser for Macular Diseases

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Brief Title

Non-damaging Retinal Laser Therapy With PASCAL Laser for Macular Diseases

Official Title

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 Phase

Phase 2

Study Type

Interventional


Primary Outcome

Best corrected visual acuity

Secondary Outcome

 Central macular thickness on OCT

Condition

Diabetic Macular Edema

Intervention

Topcon Endpoint Management

Study Arms / Comparison Groups

 Topcon Endpoint management
Description:  Active laser treatment

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Procedure

Estimated Enrollment

20

Start Date

March 2013

Completion Date

April 2020

Primary Completion Date

April 2020

Eligibility Criteria

        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.
      

Gender

All

Ages

18 Years - 100 Years

Accepts Healthy Volunteers

No

Contacts

Daniel Lavinsky, MD, PhD, +555133302444, [email protected]

Location Countries

Brazil

Location Countries

Brazil

Administrative Informations


NCT ID

NCT01975103

Organization ID

EPM-001


Responsible Party

Principal Investigator

Study Sponsor

Federal University of Rio Grande do Sul


Study Sponsor

Daniel Lavinsky, MD, PhD, Principal Investigator, Federal University of Rio Grande do Sul


Verification Date

November 2018