Back to resultsSubthreshold Laser Treatment for Reticular Pseudodrusen and Geographic Atrophy Secondary to AMD
Primary Purpose
Age-Related Macular Degeneration, Geographic Atrophy, Reticular Pseudodrusen
Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Subthreshold 577 nm yellow wavelength laser photo-coagulator
Sponsored by
About this trial
This is an interventional treatment trial for Age-Related Macular Degeneration focused on measuring Age-Related Macular Degeneration, Geographic Atrophy, Reticular pseudodrusen, Lasers, PASCAL 577
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
Sites / Locations
- Ospedale San Raffaele
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Pseudodrusen
Geographic atrophy
Arm Description
Subthreshold 577 nm yellow wavelength laser photo-coagulator
Subthreshold 577 nm yellow wavelength laser photo-coagulator
Outcomes
Primary Outcome Measures
Retinal Sensitivity
Change in retinal sensitivity on customized microperimetry (treated area).
Secondary Outcome Measures
Visual Acuity
Change in mean Visual Acuity
The Thickness of the Outer Nuclear Layer in the Treated Area
The thickness of the outer nuclear layer in the treated area was measured using structural OCT
Adverse and Serious Adverse Events
Adverse and Serious Adverse Events were recorded
Presence of Haemorrhage, Photocoagulation Spots, Ischemic Areas
Fundus examination by using slit-lamp was performed in order to assess the presence of hemorrhage, photocoagulation spots, ischemic areas
Intraocular Pressure
Intraocular pressure was recorded.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02800356
Brief Title
Subthreshold Laser Treatment for Reticular Pseudodrusen and Geographic Atrophy Secondary to AMD
Official Title
Subthreshold Laser Treatment for Reticular Pseudodrusen and Incipient Geographic Atrophy Secondary to Age - Related Macular Degeneration: a Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
June 2016 (undefined)
Primary Completion Date
September 1, 2019 (Actual)
Study Completion Date
September 1, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ospedale San Raffaele
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Age-Related Macular Degeneration, Geographic Atrophy, Reticular Pseudodrusen
Keywords
Age-Related Macular Degeneration, Geographic Atrophy, Reticular pseudodrusen, Lasers, PASCAL 577
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Pseudodrusen
Arm Type
Experimental
Arm Description
Subthreshold 577 nm yellow wavelength laser photo-coagulator
Arm Title
Geographic atrophy
Arm Type
Experimental
Arm Description
Subthreshold 577 nm yellow wavelength laser photo-coagulator
Intervention Type
Procedure
Intervention Name(s)
Subthreshold 577 nm yellow wavelength laser photo-coagulator
Other Intervention Name(s)
Pascal Synthesis 577 (Topcon), Subthreshold laser
Intervention Description
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.
Primary Outcome Measure Information:
Title
Retinal Sensitivity
Description
Change in retinal sensitivity on customized microperimetry (treated area).
Time Frame
Baseline, 4 weeks and 12 weeks
Secondary Outcome Measure Information:
Title
Visual Acuity
Description
Change in mean Visual Acuity
Time Frame
Baseline, 4 weeks and 12 weeks
Title
The Thickness of the Outer Nuclear Layer in the Treated Area
Description
The thickness of the outer nuclear layer in the treated area was measured using structural OCT
Time Frame
Baseline, 4 weeks and 12 weeks
Title
Adverse and Serious Adverse Events
Description
Adverse and Serious Adverse Events were recorded
Time Frame
4 weeks and 12 weeks
Title
Presence of Haemorrhage, Photocoagulation Spots, Ischemic Areas
Description
Fundus examination by using slit-lamp was performed in order to assess the presence of hemorrhage, photocoagulation spots, ischemic areas
Time Frame
4 weeks and 12 weeks
Title
Intraocular Pressure
Description
Intraocular pressure was recorded.
Time Frame
4 weeks and 12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Giuseppe Querques, MD, PhD
Organizational Affiliation
Ospedale San Raffaele
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Riccardo Sacconi, MD
Organizational Affiliation
Ospedale San Raffaele
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Francesco Gelormini, MDs
Organizational Affiliation
Ospedale San Raffaele
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ospedale San Raffaele
City
Milan
State/Province
MI
ZIP/Postal Code
20132
Country
Italy
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
15615751
Citation
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.
Results Reference
background
PubMed Identifier
16996596
Citation
Parodi 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.
Results Reference
background
PubMed Identifier
19041477
Citation
Chen 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.
Results Reference
background
PubMed Identifier
24837050
Citation
Luttrull 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.
Results Reference
background
PubMed Identifier
25650711
Citation
Luttrull 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.
Results Reference
background
PubMed Identifier
25719988
Citation
Vujosevic 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.
Results Reference
background
PubMed Identifier
16340527
Citation
Bessho 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.
Results Reference
background
PubMed Identifier
26493180
Citation
Virgili 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.
Results Reference
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Subthreshold Laser Treatment for Reticular Pseudodrusen and Geographic Atrophy Secondary to AMD
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