Subthreshold Laser Treatment for Reticular Pseudodrusen Secondary to Age-related Macular Degeneration

Launched by OSPEDALE SAN RAFFAELE · Apr 12, 2021

Keywords

ClinConnect Summary

This clinical trial is exploring a new type of laser treatment called subthreshold laser treatment for patients with reticular pseudodrusen, a condition related to age-related macular degeneration (AMD). The goal is to see if this treatment can help maintain or improve the sensitivity of the retina and prevent the condition from worsening into more serious forms of vision loss. The study involves about 50 participants who will receive the laser treatment and will be monitored over the course of a year through various eye exams.

To participate in this study, individuals must be 50 years or older, have reticular pseudodrusen caused by AMD, and have a range of vision that allows for participation. Participants will undergo several evaluations at the start and at 3, 6, and 9 months after treatment, with a comprehensive eye exam at the end of the year. This trial is currently recruiting, and it is important for potential participants to be aware of certain exclusion criteria, such as having other specific eye conditions or recent eye surgeries that might affect their eligibility. If you or someone you know meets the eligibility criteria, this could be an opportunity to contribute to important research aimed at preserving vision for individuals with AMD.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 50 years or older
• • Presence of RPD secondary to AMD
• • Best-corrected visual acuity (BCVA) between 20/20 and 20/400 inclusive
• • Clear ocular media
• • Ability to provide informed consent and attend all study visits
• Exclusion Criteria:
• • Presence of Geographic Atrophy (GA)
• • Evidence of choroidal neovascularization in either eye
• • Any prior treatment for AMD, aside from antioxidants
• • Any corneal opacity, cataract formation and hemorrhage in the vitreous body, which may interfere with viewing by the laser surgeon of the target structures
• • Aphakic eye with vitreous in the anterior chamber
• • Neovascular Glaucoma
• • Glaucoma caused by congenital angle anomalies
• • Open angle of less than 90º or extensive peripheral anterior and low synechia, present circumferentially around the corner
• • Significant corneal edema or reduced water clarity that obscures the view angle in detail
• • Glaucoma secondary to active uveitis
• • 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 (further definition can be found in Section 12.7) 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