ClinicalTrials.gov
ClinicalTrials.gov Menu

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01975103
Recruitment Status : Recruiting
First Posted : November 4, 2013
Last Update Posted : November 14, 2018
Sponsor:
Information provided by (Responsible Party):
Daniel Lavinsky, Federal University of Rio Grande do Sul

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.

Condition or disease Intervention/treatment Phase
Diabetic Macular Edema Branch Retinal Vein Occlusion Chronic Central Serous Retinopathy Macular Telangiectasia Procedure: Topcon Endpoint Management Phase 2

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 : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
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
Official Title: Phase 2 Study of Non-damaging Retinal Laser Therapy Using PASCAL Laser With Endpoint Management Software for Macular Diseases
Study Start Date : March 2013
Estimated Primary Completion Date : April 2020
Estimated Study Completion Date : April 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Topcon Endpoint management
Active laser treatment
Procedure: Topcon Endpoint Management
Sham Comparator: Control
Powerless (sham) laser treatment
Procedure: Topcon Endpoint Management



Primary Outcome Measures :
  1. Best corrected visual acuity [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Central macular thickness on OCT [ Time Frame: 6 months ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01975103


Contacts
Contact: Daniel Lavinsky, MD, PhD +555133302444 daniellavinsky@gmail.com

Locations
Brazil
Instituto de Oftalmologia Lavinsky Recruiting
Porto Alegre, RS, Brazil, 90440051
Contact: Daniel Lavinsky, MD, PhD    +5551982092999    daniellavinsky@gmail.com   
Principal Investigator: Daniel Lavinsky, MD, PhD         
Sponsors and Collaborators
Federal University of Rio Grande do Sul
Investigators
Principal Investigator: Daniel Lavinsky, MD, PhD Federal University of Rio Grande do Sul

Publications:
Responsible Party: Daniel Lavinsky, Professor, Federal University of Rio Grande do Sul
ClinicalTrials.gov Identifier: NCT01975103     History of Changes
Other Study ID Numbers: EPM-001
First Posted: November 4, 2013    Key Record Dates
Last Update Posted: November 14, 2018
Last Verified: November 2018

Additional relevant MeSH terms:
Retinal Diseases
Macular Edema
Retinal Vein Occlusion
Telangiectasis
Central Serous Chorioretinopathy
Macular Degeneration
Retinal Degeneration
Eye Diseases
Venous Thrombosis
Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases