Subthreshold Laser Treatment for Reticular Pseudodrusen and Geographic Atrophy Secondary to AMD

February 2, 2020 updated by: Querques Giuseppe, Ospedale San Raffaele

Subthreshold Laser Treatment for Reticular Pseudodrusen and Incipient Geographic Atrophy Secondary to Age - Related Macular Degeneration: a Pilot Study

To evaluate the effectiveness of subthreshold laser treatment on retinal sensitivity in patients with reticular pseudodrusen and incipient Geographic Atrophy (GA) secondary to Age-Related Macular Degeneration (AMD). Secondary objective is to investigate changes in best-corrected visual acuity, atrophy progression and safety.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • MI
      • Milan, MI, Italy, 20132
        • Ospedale San Raffaele

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • GA < 0.5 disk areas secondary to AMD and/or Reticular pseudodrusen
  • 50 years or older
  • The periphery of the atrophic lesions must demonstrate increased autofluorescence
  • Best corrected visual acuity between 20/20 and 20/400 inclusive
  • Clear ocular media
  • Ability to provide informed consent and attend all study visits

Exclusion Criteria:

  • GA secondary to other causes aside from AMD
  • Evidence of choroidal neovascularization in either eye
  • Any prior treatment for AMD, aside from antioxidants
  • Any other ocular condition that would progress in the study period and confound visual acuity assessment
  • Any ocular or systemic medication known to be toxic to the lens, retina or optic nerve
  • Presence of idiopathic or autoimmune-associated uveitis
  • Any intraocular surgery 3 months of entry
  • Any prior thermal laser in the macula
  • History of vitrectomy, filtering surgery, corneal transplant or retinal detachment surgery
  • Previous therapeutic radiation in the ocular region in either eye
  • Any treatment with an investigational agent in the previous 60 days before study entry
  • Women of child-bearing potential, defined as all women less than 1 year postmenopausal or less than 6 weeks since sterilization at Baseline, unless they are using highly effective methods of contraception during dosing of study treatment
  • Participation in an investigational drug, biologic, or device study within 6 Months prior to Baseline [Note: observational clinical studies solely involving over-the-counter vitamins, supplements, or diets are not exclusionary

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Pseudodrusen
Subthreshold 577 nm yellow wavelength laser photo-coagulator
Procedure: Subthreshold 577 nm yellow wavelength laser photo-coagulator

Subthreshold photocoagulation is a method in which the burn spots (treated areas) cannot be seen with biomicroscopy, on color fundus photograph, on Optical Coherence Tomography or Fluorescein Angiography when the subthreshold level is adequately set. Subthreshold photocoagulation can be considered to be truly minimally invasive or non-damaging photocoagulation. A term sometimes used is photo-thermal stimulation since the Retinal Pigment Epithelium (RPE) layer is heated and stimulated, but not destroyed.

The threshold level output power is set to obtain barely visible burn at approximately 200 mW to 250 mW using the titration mode, and irradiation is conducted after switching over to Endpoint Management.

Other Names:
  • Pascal Synthesis 577 (Topcon)
  • Subthreshold laser
Experimental: Geographic atrophy
Subthreshold 577 nm yellow wavelength laser photo-coagulator
Procedure: Subthreshold 577 nm yellow wavelength laser photo-coagulator

Subthreshold photocoagulation is a method in which the burn spots (treated areas) cannot be seen with biomicroscopy, on color fundus photograph, on Optical Coherence Tomography or Fluorescein Angiography when the subthreshold level is adequately set. Subthreshold photocoagulation can be considered to be truly minimally invasive or non-damaging photocoagulation. A term sometimes used is photo-thermal stimulation since the Retinal Pigment Epithelium (RPE) layer is heated and stimulated, but not destroyed.

The threshold level output power is set to obtain barely visible burn at approximately 200 mW to 250 mW using the titration mode, and irradiation is conducted after switching over to Endpoint Management.

Other Names:
  • Pascal Synthesis 577 (Topcon)
  • Subthreshold laser

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Retinal Sensitivity
Time Frame: Baseline, 4 weeks and 12 weeks
Change in retinal sensitivity on customized microperimetry (treated area).
Baseline, 4 weeks and 12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual Acuity
Time Frame: Baseline, 4 weeks and 12 weeks
Change in mean Visual Acuity
Baseline, 4 weeks and 12 weeks
The Thickness of the Outer Nuclear Layer in the Treated Area
Time Frame: Baseline, 4 weeks and 12 weeks
The thickness of the outer nuclear layer in the treated area was measured using structural OCT
Baseline, 4 weeks and 12 weeks
Adverse and Serious Adverse Events
Time Frame: 4 weeks and 12 weeks
Adverse and Serious Adverse Events were recorded
4 weeks and 12 weeks
Presence of Haemorrhage, Photocoagulation Spots, Ischemic Areas
Time Frame: 4 weeks and 12 weeks
Fundus examination by using slit-lamp was performed in order to assess the presence of hemorrhage, photocoagulation spots, ischemic areas
4 weeks and 12 weeks
Intraocular Pressure
Time Frame: 4 weeks and 12 weeks
Intraocular pressure was recorded.
4 weeks and 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ospedale San Raffaele

Investigators

  • Principal Investigator: Giuseppe Querques, MD, PhD, Ospedale San Raffaele
  • Principal Investigator: Riccardo Sacconi, MD, Ospedale San Raffaele
  • Principal Investigator: Francesco Gelormini, MDs, Ospedale San Raffaele

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2016

Primary Completion (Actual)

September 1, 2019

Study Completion (Actual)

September 1, 2019

Study Registration Dates

First Submitted

June 2, 2016

First Submitted That Met QC Criteria

June 10, 2016

First Posted (Estimate)

June 15, 2016

Study Record Updates

Last Update Posted (Actual)

February 17, 2020

Last Update Submitted That Met QC Criteria

February 2, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PASCAL-GA

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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