Subthreshold Laser Treatment for Reticular Pseudodrusen Secondary to Age-related Macular Degenera… (NCT04847635) | Clinical Trial Compass
RecruitingNot Applicable
Subthreshold Laser Treatment for Reticular Pseudodrusen Secondary to Age-related Macular Degeneration
Italy50 participantsStarted 2021-03-16
Plain-language 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.
Who can participate
Age range
55 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 previ…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Changes in the retinal sensitivity - 12 months
Timeframe: 12 months
2
Anatomical changes using structural optical coherence tomography (OCT)