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| Name | Class |
|---|---|
| Fondazione G.B. Bietti, IRCCS | OTHER |
| University of Genova | OTHER |
| University of Rome Tor Vergata | OTHER |
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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 naĂŻve 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Subthreshold laser group | Experimental | To evaluate the efficacy of Subthreshold laser in the treatment of reticular pseudodrusen. |
|
| Sham group | Sham Comparator | The light from the retinal illumination system on the laser device will be used instead of the laser beam in all follow-up evaluations. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pascal Synthesis 577 sub-threshold laser (Topcon Corporation, Tokyo, Japan) | Device | The subthreshold laser treatment will be performed using subthreshold laser Pascal Synthesis 577 on a customized macular area. |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in the retinal sensitivity - 12 months | Functional changes in the retinal sensitivity on customized microperimetry from day 0 to month 12 (unit of measure: dB) | 12 months |
| Anatomical changes using structural optical coherence tomography (OCT) | Anatomical changes will be evaluated with retinal thickness (unit of measure: microns) | 12 months |
| Rate of Progression | Rate of progression to advance AMD (GA and/or neovascular AMD) | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in the retinal sensitivity - 6 months | Functional changes in the retinal sensitivity on customized microperimetry from day 0 to month 6 (unit of measure: dB) | 6 months |
| Anatomical changes using fundus autofluorescence (FAF) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Giuseppe Querques, MD, PhD | Contact | +390226434004 | querques.giuseppe@hsr.it |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massimo Nicolò | Recruiting | Genova | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33500505 | Background | Querques G, Sacconi R, Gelormini F, Borrelli E, Prascina F, Zucchiatti I, Querques L, Bandello F. Subthreshold laser treatment for reticular pseudodrusen secondary to age-related macular degeneration. Sci Rep. 2021 Jan 26;11(1):2193. doi: 10.1038/s41598-021-81810-7. |
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Prospective, randomized, longitudinal, interventional study
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| Pascal Synthesis 577 sham (Topcon Corporation, Tokyo, Japan) | Device | The laser treatment will be performed without any power (only the light beam) using subthreshold laser Pascal Synthesis 577 on a customized macular area. |
|
Anatomical changes will be evaluated analyzing the development of geographic atrophy using FAF
| 12 months |
| Genetic influence (% of AMD-associated single-nucleotide polymorphism (SNP) in treated patients) | The % of AMD-associated single-nucleotide polymorphism (SNP) will be evaluated analyzing the % of patients with an AMD-associated SNP in patients showing no progression vs progression to advance AMD (main outcome 3). | 12 months |
| Anatomical changes using OCT-angiography (OCT-A) | Anatomical changes will be evaluated analyzing the perfusion density by means of OCT-A | 12 months |
| Giuseppe Querques | Recruiting | Milan | 20134 | Italy |
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| Mariacristina Parravano | Recruiting | Rome | Italy |
|
| ID | Term |
|---|---|
| C562479 | Macular Degeneration, Age-Related, 2 |
| D057092 | Geographic Atrophy |
| D008268 | Macular Degeneration |
| ID | Term |
|---|---|
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
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