Status:
RECRUITING
Subthreshold Laser Treatment for Reticular Pseudodrusen Secondary to Age-related Macular Degeneration
Lead Sponsor:
Ospedale San Raffaele
Collaborating Sponsors:
Fondazione G.B. Bietti, IRCCS
University of Genova
Conditions:
Macular Degeneration, Senile
Laser Burn of Retina
Eligibility:
All Genders
55+ years
Phase:
NA
Brief Summary
Prospective, randomized, controlled, longitudinal, interventional multicentric study involving patients with reticular pseudodrusen secondary to AMD. The objective of this study is to establish the e...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 16 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2026
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT04847635
Start Date
March 16 2021
End Date
September 1 2026
Last Update
March 12 2025
Active Locations (3)
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1
Massimo Nicolò
Genova, Italy
2
Giuseppe Querques
Milan, Italy, 20134
3
Mariacristina Parravano
Rome, Italy