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

Not Applicable

Completed

Conditions: Geographic Atrophy
Reticular Pseudodrusen
Age-Related Macular Degeneration

Interventions: Procedure: Subthreshold 577 nm yellow wavelength laser photo-coagulator

Brief Summary: 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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Pseudodrusen	Subthreshold 577 nm yellow wavelength laser photo-coagulator	Subthreshold 577 nm yellow wavelength laser photo-coagulator
Geographic atrophy	Subthreshold 577 nm yellow wavelength laser photo-coagulator	Subthreshold 577 nm yellow wavelength laser photo-coagulator

Primary Outcome Measures

Name	Time	Method
Retinal Sensitivity	Baseline, 4 weeks and 12 weeks	Change in retinal sensitivity on customized microperimetry (treated area).

Secondary Outcome Measures

Name	Time	Method
Visual Acuity	Baseline, 4 weeks and 12 weeks	Change in mean Visual Acuity
The Thickness of the Outer Nuclear Layer in the Treated Area	Baseline, 4 weeks and 12 weeks	The thickness of the outer nuclear layer in the treated area was measured using structural OCT
Number of Partecipants With Adverse and Serious Adverse Events	4 weeks and 12 weeks	Adverse and Serious Adverse Events were recorded
Number of Partecipants With Presence of Haemorrhage, Photocoagulation Spots, Ischemic Areas	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
Intraocular Pressure	4 weeks and 12 weeks	Intraocular pressure was recorded.