Laser treatment for reticular pseudodrusen in age-related macular degeneration

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional study aims to evaluate the effectiveness of subthreshold laser treatment in patients with reticular pseudodrusen secondary to age-related macular degeneration (AMD). Approximately 50 patients aged 50 and older will be randomized into two groups, one receiving the laser treatment and the other a sham treatment. Participants will undergo evaluations at baseline and at 3, 6, 9, and 12 months, including visual acuity measurements and advanced imaging techniques. The goal is to prevent the progression of reticular pseudodrusen to atrophic degeneration and to improve retinal sensitivity.

Why it matters

Who can join: the full rules

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

Where it's running

• Massimo Nicolò
  Genova, Italy Recruiting
• Giuseppe Querques
  Milan, Italy Recruiting
• Mariacristina Parravano
  Rome, Italy Recruiting

Study contacts

• Study coordinator: Giuseppe Querques, MD, PhD
• Email: querques.giuseppe@hsr.it
• Phone: +390226434004

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.