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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-06-30

Study Completion Date

2019-09-01

Brief Summary

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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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Detailed Description

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Conditions

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Age-Related Macular Degeneration Geographic Atrophy Reticular Pseudodrusen

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Pseudodrusen

Subthreshold 577 nm yellow wavelength laser photo-coagulator

Group Type EXPERIMENTAL

Subthreshold 577 nm yellow wavelength laser photo-coagulator

Intervention Type 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.

Geographic atrophy

Subthreshold 577 nm yellow wavelength laser photo-coagulator

Group Type EXPERIMENTAL

Subthreshold 577 nm yellow wavelength laser photo-coagulator

Intervention Type 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.

Interventions

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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.

Intervention Type PROCEDURE

Other Intervention Names

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Pascal Synthesis 577 (Topcon) Subthreshold laser

Eligibility Criteria

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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

Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No