Clinical trial NCT04847635: Subthreshold Laser Treatment for Reticular Pseudodrusen Secondary to Age-related Macular Degeneration
Official title: Subthreshold Laser Treatment for Reticular Pseudodrusen Secondary to Age-related Macular Degeneration
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Macular Degeneration, Senile
Laser Burn of Retina
Macular Degeneration Intermediate
Macular Degeneration, Dry
Keywords: Retina
Age-related macular degeneration
Reticular pseudodrusen
Sub-threshold laser
Lead sponsor: Ospedale San Raffaele
Sponsor class: OTHER
Collaborators: name: Fondazione G.B. Bietti, IRCCS
name: University of Genova
name: University of Rome Tor Vergata
First posted: 2021-04-19
Enrollment: 50
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective, randomized, longitudinal, interventional study
Primary purpose: TREATMENT

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 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.


Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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

Primary outcomes:
measure: Changes in the retinal sensitivity - 12 months
timeFrame: 12 months
measure: Anatomical changes using structural optical coherence tomography (OCT)
timeFrame: 12 months
measure: Rate of Progression
timeFrame: 12 months
Secondary outcomes:
measure: Changes in the retinal sensitivity - 6 months
timeFrame: 6 months
measure: Anatomical changes using fundus autofluorescence (FAF)
timeFrame: 12 months
measure: Genetic influence (% of AMD-associated single-nucleotide polymorphism (SNP) in treated patients)
timeFrame: 12 months
measure: Anatomical changes using OCT-angiography (OCT-A)
timeFrame: 12 months
Other outcomes:
Locations:
city: Genova
country: Italy
facility: Massimo Nicolò
city: Milan
country: Italy
facility: Giuseppe Querques
city: Rome
country: Italy
facility: Mariacristina Parravano
Study officials:
References:
citation: 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.