Laser treatment for reticular pseudodrusen in age-related macular degeneration
Subthreshold Laser Treatment for Reticular Pseudodrusen Secondary to Age-related Macular Degeneration
This study is testing whether a special laser treatment can help older adults with reticular pseudodrusen from age-related macular degeneration by preventing further vision loss.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 55 Years and up |
| Sex | All |
| Sponsor | Ospedale San Raffaele Academic / other |
| Drugs / interventions | radiation |
| Locations | 3 sites (Genova and 2 other locations) |
| Trial ID | NCT04847635 on ClinicalTrials.gov |
What this trial studies
This interventional study aims to evaluate the effectiveness of subthreshold laser treatment in patients with reticular pseudodrusen secondary to age-related macular degeneration (AMD). Approximately 50 patients aged 50 and older will be randomized into two groups, one receiving the laser treatment and the other a sham treatment. Participants will undergo evaluations at baseline and at 3, 6, 9, and 12 months, including visual acuity measurements and advanced imaging techniques. The goal is to prevent the progression of reticular pseudodrusen to atrophic degeneration and to improve retinal sensitivity.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 50 or older with reticular pseudodrusen secondary to AMD and a best-corrected visual acuity between 20/20 and 20/400.
Not a fit: Patients with geographic atrophy, choroidal neovascularization, or prior treatments for AMD may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could help preserve vision and prevent further degeneration in patients with reticular pseudodrusen.
How similar studies have performed: While the approach of using subthreshold laser treatment is promising, it is relatively novel and has not been extensively tested in similar studies.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Genova and 2 other locations
- Massimo Nicolò — Genova, Italy (Recruiting)
- Giuseppe Querques — Milan, Italy (Recruiting)
- Mariacristina Parravano — Rome, Italy (Recruiting)
Study contacts
- Study coordinator: Giuseppe Querques, MD, PhD
- Email: querques.giuseppe@hsr.it
- Phone: +390226434004
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.