Trials / Recruiting
RecruitingNCT04847635
Subthreshold Laser Treatment for Reticular Pseudodrusen Secondary to Age-related Macular Degeneration
- Status
- Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 50 (estimated)
- Sponsor
- Ospedale San Raffaele · Academic / Other
- Sex
- All
- Age
- 55 Years
- Healthy volunteers
- Not accepted
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 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
- Macular Degeneration, Senile
- Laser Burn of Retina
- Macular Degeneration Intermediate
- Macular Degeneration, Dry
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Pascal Synthesis 577 sub-threshold laser (Topcon Corporation, Tokyo, Japan) | The subthreshold laser treatment will be performed using subthreshold laser Pascal Synthesis 577 on a customized macular area. |
| DEVICE | Pascal Synthesis 577 sham (Topcon Corporation, Tokyo, Japan) | The laser treatment will be performed without any power (only the light beam) using subthreshold laser Pascal Synthesis 577 on a customized macular area. |
Timeline
- Start date
- 2021-03-16
- Primary completion
- 2026-09-01
- Completion
- 2026-09-01
- First posted
- 2021-04-19
- Last updated
- 2025-03-12
Locations
3 sites across 1 country: Italy
Source: ClinicalTrials.gov record NCT04847635. Inclusion in this directory is not an endorsement.