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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pseudodrusen | Experimental | Subthreshold 577 nm yellow wavelength laser photo-coagulator |
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| Geographic atrophy | Experimental | Subthreshold 577 nm yellow wavelength laser photo-coagulator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Subthreshold 577 nm yellow wavelength laser photo-coagulator | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Retinal Sensitivity | Change in retinal sensitivity on customized microperimetry (treated area). | Baseline, 4 weeks and 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Visual Acuity | Change in mean Visual Acuity | Baseline, 4 weeks and 12 weeks |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Giuseppe Querques, MD, PhD | Ospedale San Raffaele | Principal Investigator |
| Riccardo Sacconi, MD | Ospedale San Raffaele | Principal Investigator |
| Francesco Gelormini, MDs | Ospedale San Raffaele | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ospedale San Raffaele | Milan | MI | 20132 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15615751 | Background | 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. | |
| 16996596 | Background | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Pseudodrusen | Patients affected by reticular pseudodrusen secondary to AMD were included and treated by subthreshold 577 nm yellow wavelength laser photo-coagulator. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Pseudodrusen | Patients affected by reticular pseudodrusen secondary to AMD were included and treated by subthreshold 577 nm yellow wavelength laser photo-coagulator. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Retinal Sensitivity | Change in retinal sensitivity on customized microperimetry (treated area). | Posted | Mean | Standard Deviation | dB | Baseline, 4 weeks and 12 weeks |
|
|
12 weeks.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Pseudodrusen | Patients affected by reticular pseudodrusen secondary to AMD were included and treated by subthreshold 577 nm yellow wavelength laser photo-coagulator. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Prof. Giuseppe Querques | San Raffaele Hospital | 00390226434004 | querques.giuseppe@hsr.it |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 1, 2020 | Feb 2, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D008268 | Macular Degeneration |
| D057092 | Geographic Atrophy |
| ID | Term |
|---|---|
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
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|
|
| Baseline, 4 weeks and 12 weeks |
| Number of Partecipants With Adverse and Serious Adverse Events | Adverse and Serious Adverse Events were recorded | 4 weeks and 12 weeks |
| Number of Partecipants With 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 | 4 weeks and 12 weeks |
| Intraocular Pressure | Intraocular pressure was recorded. | 4 weeks and 12 weeks |
| 19041477 | Background | 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. |
| 24837050 | Background | 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. |
| 25650711 | Background | 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. |
| 25719988 | Background | 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. |
| 16340527 | Background | 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. |
| 26493180 | Background | 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. |
| Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Retinal sensitivity in the treated area | Mean | Standard Deviation | dB |
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| Secondary | Visual Acuity | Change in mean Visual Acuity | Posted | Mean | Standard Deviation | LogMAR | Baseline, 4 weeks and 12 weeks |
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| Secondary | 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 | Posted | Mean | Standard Deviation | µm | Baseline, 4 weeks and 12 weeks |
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| Secondary | Number of Partecipants With Adverse and Serious Adverse Events | Adverse and Serious Adverse Events were recorded | Posted | Count of Participants | Participants | 4 weeks and 12 weeks |
|
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| Secondary | Number of Partecipants With 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 | Posted | Count of Participants | Participants | 4 weeks and 12 weeks |
|
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| Secondary | Intraocular Pressure | Intraocular pressure was recorded. | Posted | Mean | Standard Deviation | mmHg | 4 weeks and 12 weeks |
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| 0 |
| 20 |
| 0 |
| 20 |
| 0 |
| 20 |
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