N/A
N=20
Subthreshold Laser Treatment for Reticular Pseudodrusen and Geographic Atrophy Secondary to AMD
Age-Related Macular Degeneration · Geographic Atrophy · Reticular Pseudodrusen
Bottom Line
View on ClinicalTrials.gov: NCT02800356 ↗Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Feb 2020
Primary outcome: Primary: Retinal Sensitivity — 12.08; 11.08; 11.45 dB — p=0.404
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Subthreshold 577 nm yellow wavelength laser photo-coagulator (Procedure)
- Age
- Adult, Older Adult · 50+ yrs
- Sex
- All
- Sponsor
- Ospedale San Raffaele
- Primary completion
- Sep 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Retinal Sensitivity |
12.08; 11.08; 11.45 | 0.404 |
| SECONDARY Visual Acuity |
0.14; 0.135; 0.115 | 0.232 |
| SECONDARY The Thickness of the Outer Nuclear Layer in the Treated Area |
59.30; 64.75; 67.75 | 0.001 sig |
| SECONDARY Number of Partecipants With Adverse and Serious Adverse Events |
— | — |
| SECONDARY Number of Partecipants With Presence of Haemorrhage, Photocoagulation Spots, Ischemic Areas |
— | — |
| SECONDARY Intraocular Pressure |
15.5; 14.9; 14.7 | 0.267 |
Summary
To evaluate the effectiveness of subthreshold laser treatment on retinal sensitivity in patients with reticular pseudodrusen and incipient Geographic Atrophy (GA) secondary to Age-Related Macular Degeneration (AMD). Secondary objective is to investigate changes in best-corrected visual acuity, atrophy progression and safety.
Eligibility Criteria
Inclusion Criteria
- GA < 0.5 disk areas secondary to AMD and/or Reticular pseudodrusen
- 50 years or older
- The periphery of the atrophic lesions must demonstrate increased autofluorescence
- Best corrected visual acuity between 20/20 and 20/400 inclusive
- Clear ocular media
- Ability to provide informed consent and attend all study visits
Exclusion Criteria
- GA secondary to other causes aside from AMD
- Evidence of choroidal neovascularization in either eye
- Any prior treatment for AMD, aside from antioxidants
- 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 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
Data sourced from ClinicalTrials.gov (NCT02800356). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.