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

Study Overview
=================
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.

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

Conditions
-----------------
Age-Related Macular Degeneration, Geographic Atrophy, Reticular Pseudodrusen

Intervention / Treatment
-----------------
* Procedure: Subthreshold 577 nm yellow wavelength laser photo-coagulator


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 50 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pseudodrusen<br>Subthreshold 577 nm yellow wavelength laser photo-coagulator | Procedure: Subthreshold 577 nm yellow wavelength laser photo-coagulator<br>* 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.<br>* Other names: Subthreshold laser;|
| Experimental: Geographic atrophy<br>Subthreshold 577 nm yellow wavelength laser photo-coagulator | Procedure: Subthreshold 577 nm yellow wavelength laser photo-coagulator<br>* 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.<br>* Other names: Subthreshold laser;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Retinal Sensitivity | 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 | Change in mean Visual Acuity | Baseline, 4 weeks and 12 weeks | 
| The Thickness of the Outer Nuclear Layer in the Treated Area | 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 | Adverse and Serious Adverse Events were recorded | 4 weeks and 12 weeks | 
| Presence of Haemorrhage, Photocoagulation Spots, Ischemic Areas | 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 | Intraocular pressure was recorded. | 4 weeks and 12 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Age-Related Macular Degeneration, Geographic Atrophy, Reticular pseudodrusen, Lasers, PASCAL 577