Subthreshold Laser Treatment for Reticular Pseudodrusen and Geographic Atrophy Secondary to AMD

Age-Related Macular Degeneration Clinical Trial

Official title:

Subthreshold Laser Treatment for Reticular Pseudodrusen and Incipient Geographic Atrophy Secondary to Age - Related Macular Degeneration: a Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02800356
• Other study ID #: PASCAL-GA
• Status: Completed
• Phase: N/A
• Start date: June 2016
• Est. completion date: September 1, 2019

Study information

• Verified date: February 2020
• Source: Ospedale San Raffaele
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: September 1, 2019
• Est. primary completion date: September 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Age-Related Macular Degeneration
• Atrophy
• Geographic Atrophy
• Macular Degeneration
• Reticular Pseudodrusen
• Retinal Drusen

Intervention

Procedure:
• Subthreshold 577 nm yellow wavelength laser photo-coagulator
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.

Locations

Country	Name	City	State
Italy	Ospedale San Raffaele	Milan	MI

Sponsors (1)

Lead Sponsor	Collaborator
Ospedale San Raffaele

Country where clinical trial is conducted

Italy, 

References & Publications (8)

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. — View 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. — View 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. — View 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. — View 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. — View 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. Epub 2006 Sep 25. — View 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;(10):CD006537. doi: 10.1002/14651858.CD006537.pub3. Review. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Retinal Sensitivity	Change in retinal sensitivity on customized microperimetry (treated area).	Baseline, 4 weeks and 12 weeks
Secondary	Visual Acuity	Change in mean Visual Acuity	Baseline, 4 weeks and 12 weeks
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	Baseline, 4 weeks and 12 weeks
Secondary	Adverse and Serious Adverse Events	Adverse and Serious Adverse Events were recorded	4 weeks and 12 weeks
Secondary	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
Secondary	Intraocular Pressure	Intraocular pressure was recorded.	4 weeks and 12 weeks