Subthreshold Laser Treatment for Reticular Pseudodrusen and Geographic Atrophy Secondary to AMD
1 other identifier
interventional
20
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jun 2016
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2016
CompletedFirst Submitted
Initial submission to the registry
June 2, 2016
CompletedFirst Posted
Study publicly available on registry
June 15, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2019
CompletedResults Posted
Study results publicly available
February 17, 2020
CompletedMarch 20, 2025
March 1, 2025
3.3 years
June 2, 2016
February 2, 2020
March 11, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Retinal Sensitivity
Change in retinal sensitivity on customized microperimetry (treated area).
Baseline, 4 weeks and 12 weeks
Secondary Outcomes (5)
Visual Acuity
Baseline, 4 weeks and 12 weeks
The Thickness of the Outer Nuclear Layer in the Treated Area
Baseline, 4 weeks and 12 weeks
Number of Partecipants With Adverse and Serious Adverse Events
4 weeks and 12 weeks
Number of Partecipants With Presence of Haemorrhage, Photocoagulation Spots, Ischemic Areas
4 weeks and 12 weeks
Intraocular Pressure
4 weeks and 12 weeks
Study Arms (2)
Pseudodrusen
EXPERIMENTALSubthreshold 577 nm yellow wavelength laser photo-coagulator
Geographic atrophy
EXPERIMENTALSubthreshold 577 nm yellow wavelength laser photo-coagulator
Interventions
Subthreshold photocoagulation is a method in which the burn spots (treated areas) cannot be seen with biomicroscopy, on color fundus photograph, on Optical Coherence Tomography or Fluorescein Angiography when the subthreshold level is adequately set. Subthreshold photocoagulation can be considered to be truly minimally invasive or non-damaging photocoagulation. A term sometimes used is photo-thermal stimulation since the Retinal Pigment Epithelium (RPE) layer is heated and stimulated, but not destroyed. The threshold level output power is set to obtain barely visible burn at approximately 200 mW to 250 mW using the titration mode, and irradiation is conducted after switching over to Endpoint Management.
Eligibility Criteria
You may qualify if:
- GA \< 0.5 disk areas secondary to AMD and/or Reticular pseudodrusen
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Ospedale San Raffaele
Milan, MI, 20132, Italy
Related Publications (8)
Luttrull JK, Musch DC, Mainster MA. Subthreshold diode micropulse photocoagulation for the treatment of clinically significant diabetic macular oedema. Br J Ophthalmol. 2005 Jan;89(1):74-80. doi: 10.1136/bjo.2004.051540.
PMID: 15615751BACKGROUNDParodi MB, Spasse S, Iacono P, Di Stefano G, Canziani T, Ravalico G. Subthreshold grid laser treatment of macular edema secondary to branch retinal vein occlusion with micropulse infrared (810 nanometer) diode laser. Ophthalmology. 2006 Dec;113(12):2237-42. doi: 10.1016/j.ophtha.2006.05.056. Epub 2006 Sep 25.
PMID: 16996596BACKGROUNDChen SN, Hwang JF, Tseng LF, Lin CJ. Subthreshold diode micropulse photocoagulation for the treatment of chronic central serous chorioretinopathy with juxtafoveal leakage. Ophthalmology. 2008 Dec;115(12):2229-34. doi: 10.1016/j.ophtha.2008.08.026.
PMID: 19041477BACKGROUNDLuttrull JK, Sinclair SH. Safety of transfoveal subthreshold diode micropulse laser for fovea-involving diabetic macular edema in eyes with good visual acuity. Retina. 2014 Oct;34(10):2010-20. doi: 10.1097/IAE.0000000000000177.
PMID: 24837050BACKGROUNDLuttrull JK, Chang DB, Margolis BW, Dorin G, Luttrull DK. LASER RESENSITIZATION OF MEDICALLY UNRESPONSIVE NEOVASCULAR AGE-RELATED MACULAR DEGENERATION: Efficacy and Implications. Retina. 2015 Jun;35(6):1184-94. doi: 10.1097/IAE.0000000000000458.
PMID: 25650711BACKGROUNDVujosevic S, Martini F, Longhin E, Convento E, Cavarzeran F, Midena E. SUBTHRESHOLD MICROPULSE YELLOW LASER VERSUS SUBTHRESHOLD MICROPULSE INFRARED LASER IN CENTER-INVOLVING DIABETIC MACULAR EDEMA: Morphologic and Functional Safety. Retina. 2015 Aug;35(8):1594-603. doi: 10.1097/IAE.0000000000000521.
PMID: 25719988BACKGROUNDBessho K, Rodanant N, Bartsch DU, Cheng L, Koh HJ, Freeman WR. Effect of subthreshold infrared laser treatment for drusen regression on macular autofluorescence in patients with age-related macular degeneration. Retina. 2005 Dec;25(8):981-8. doi: 10.1097/00006982-200512000-00005.
PMID: 16340527BACKGROUNDVirgili G, Michelessi M, Parodi MB, Bacherini D, Evans JR. Laser treatment of drusen to prevent progression to advanced age-related macular degeneration. Cochrane Database Syst Rev. 2015 Oct 23;2015(10):CD006537. doi: 10.1002/14651858.CD006537.pub3.
PMID: 26493180BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Prof. Giuseppe Querques
- Organization
- San Raffaele Hospital
Study Officials
- PRINCIPAL INVESTIGATOR
Giuseppe Querques, MD, PhD
Ospedale San Raffaele
- PRINCIPAL INVESTIGATOR
Riccardo Sacconi, MD
Ospedale San Raffaele
- PRINCIPAL INVESTIGATOR
Francesco Gelormini, MDs
Ospedale San Raffaele
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Head-Medical retina & Imaging unit
Study Record Dates
First Submitted
June 2, 2016
First Posted
June 15, 2016
Study Start
June 1, 2016
Primary Completion
September 1, 2019
Study Completion
September 1, 2019
Last Updated
March 20, 2025
Results First Posted
February 17, 2020
Record last verified: 2025-03