Actively Recruiting
Subthreshold Laser Treatment for Reticular Pseudodrusen Secondary to Age-related Macular Degeneration
Led by Ospedale San Raffaele · Updated on 2025-03-12
50
Participants Needed
3
Research Sites
285 weeks
Total Duration
On this page
Sponsors
O
Ospedale San Raffaele
Lead Sponsor
F
Fondazione G.B. Bietti, IRCCS
Collaborating Sponsor
AI-Summary
What this Trial Is About
Prospective, randomized, controlled, longitudinal, interventional multicentric study involving patients with reticular pseudodrusen secondary to AMD. The objective of this study is to establish the effectiveness of subthreshold laser treatment in increase/prevent the decrease of the retinal sensibility in patients with reticular pseudodrusen, and to reduce the progression of RPD to atrophy. Approximately 50 naïve patients with reticular pseudodrusen who underwent subthreshold laser treatment in perifoveal area. These patients should be randomized in the 2 study arms of the study. Patients will be evaluated at Screening/Baseline and then revaluated and retreated at month 3, 6 and 9. At month 12, all patients will be evaluated with a full ocular examination, visual acuity measurement (VA), optical coherence tomography (OCT) with autofluorescence, OCT-angiography and microperimetry. The rationale of the study is to prevent the evolution of reticular pseudodrusen to atrophic degeneration.
CONDITIONS
Official Title
Subthreshold Laser Treatment for Reticular Pseudodrusen Secondary to Age-related Macular Degeneration
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 50 years or older
- Presence of reticular pseudodrusen secondary to age-related macular degeneration
- 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
You will not qualify if you...
- 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, or hemorrhage in the vitreous body interfering with laser viewing
- Aphakic eye with vitreous in the anterior chamber
- Neovascular glaucoma
- Glaucoma caused by congenital angle anomalies
- Open angle of less than 90° or extensive peripheral anterior and low synechia around the corner
- Significant corneal edema or reduced water clarity obscuring the view angle
- Glaucoma secondary to active uveitis
- Any ocular condition that may progress and affect visual acuity assessment
- Use of ocular or systemic medication toxic to the lens, retina, or optic nerve
- Presence of idiopathic or autoimmune-associated uveitis
- Any intraocular surgery within 3 months before entry
- Any prior thermal laser treatment in the macula
- History of vitrectomy, filtering surgery, corneal transplant, or retinal detachment surgery
- Previous therapeutic radiation in the ocular region in either eye
- Treatment with an investigational agent within 60 days before study entry
- Women of child-bearing potential unless using highly effective contraception during treatment
- Participation in investigational drug, biologic, or device study within 6 months prior to baseline (except observational vitamin/supplement/diet studies)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
Massimo Nicolò
Genova, Italy
Actively Recruiting
2
Giuseppe Querques
Milan, Italy, 20134
Actively Recruiting
3
Mariacristina Parravano
Rome, Italy
Actively Recruiting
Research Team
G
Giuseppe Querques, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here