NCT04847635Recruiting
Subthreshold Laser Treatment for Reticular Pseudodrusen Secondary to Age-related Macular Degeneration
Source: ClinicalTrials.gov · Last updated 12 Mar 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 50 (estimated)
- First submitted
- 7 Apr 2021
- Start date
- 16 Mar 2021
- Primary completion date
- 1 Sept 2026
- Lead sponsor
- Ospedale San Raffaele
- Diseases
- Macular degeneration
- NCT number
- NCT04847635
What you commit to
- Study type: Interventional
- Planned participants: 50
- From 16 Mar 2021 to the primary completion date, 1 Sept 2026
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Any prior treatment for AMD, aside from antioxidants
- Any intraocular surgery 3 months of entry
- Any prior thermal laser in the macula
- Previous therapeutic radiation in the ocular region in either eye
- Any treatment with an investigational agent in the previous 60 days before study entry
- 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
Other illness
- Any corneal opacity, cataract formation and hemorrhage in the vitreous body, which may interfere with viewing by the laser surgeon of the target structures
- 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
- History of vitrectomy, filtering surgery, corneal transplant or retinal detachment surgery
Other
- Presence of Geographic Atrophy (GA)
- Evidence of choroidal neovascularization in either eye
- 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
- 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.
Who the study is looking for
- 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
Age in the registry: 55 years to - · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Massimo Nicolò Coordinator of this site? Confirm its status | Genova | Italy | Recruiting |
| Giuseppe Querques Coordinator of this site? Confirm its status | Milan | Italy | Recruiting |
| Mariacristina Parravano Coordinator of this site? Confirm its status | Rome | Italy | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.