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OpenTrials
Completed

NCT Number: NCT02800356

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

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.

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Key information

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ospedale San Raffaele

Milan, MI, 20132, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Subthreshold 577 nm yellow wavelength laser photo-coagulator

Procedure

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

Primary outcomes

  1. Retinal Sensitivity

    Time frame: Baseline, 4 weeks and 12 weeks

    Change in retinal sensitivity on customized microperimetry (treated area).

Secondary outcomes

  1. Visual Acuity

    Time frame: Baseline, 4 weeks and 12 weeks

    Change in mean Visual Acuity

  2. 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

  3. Number of Partecipants With Adverse and Serious Adverse Events

    Time frame: 4 weeks and 12 weeks

    Adverse and Serious Adverse Events were recorded

  4. Number of Partecipants With 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

  5. Intraocular Pressure

    Time frame: 4 weeks and 12 weeks

    Intraocular pressure was recorded.

Sponsors and collaborators

Lead sponsor

Ospedale San Raffaele

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Jun 15, 2016
Registry last updated
Mar 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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