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

San Donato Group (GSD)

Status

Completed

Conditions

Age-Related Macular Degeneration

Geographic Atrophy

Reticular Pseudodrusen

Treatments

Procedure: Subthreshold 577 nm yellow wavelength laser photo-coagulator

Study type

Interventional

Funder types

Other

Identifiers

NCT02800356

PASCAL-GA

Details and patient eligibility

About

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.

Enrollment

20 patients

Sex

All

Ages

50+ years old

Volunteers

No Healthy Volunteers

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