Clinical trial NCT02800356: 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
Overall status: COMPLETED
Phase: NA
Conditions: Age-Related Macular Degeneration
Geographic Atrophy
Reticular Pseudodrusen
Keywords: Age-Related Macular Degeneration
Geographic Atrophy
Reticular pseudodrusen
Lasers
PASCAL 577
Lead sponsor: Ospedale San Raffaele
Sponsor class: OTHER
First posted: 2016-06-15
Enrollment: 20
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Retinal Sensitivity
timeFrame: Baseline, 4 weeks and 12 weeks
Secondary outcomes:
measure: Visual Acuity
timeFrame: Baseline, 4 weeks and 12 weeks
measure: The Thickness of the Outer Nuclear Layer in the Treated Area
timeFrame: Baseline, 4 weeks and 12 weeks
measure: Number of Partecipants With Adverse and Serious Adverse Events
timeFrame: 4 weeks and 12 weeks
measure: Number of Partecipants With Presence of Haemorrhage, Photocoagulation Spots, Ischemic Areas
timeFrame: 4 weeks and 12 weeks
measure: Intraocular Pressure
timeFrame: 4 weeks and 12 weeks
Other outcomes:
Locations:
city: Milan
country: Italy
facility: Ospedale San Raffaele
state: MI
Study officials:
affiliation: Ospedale San Raffaele
name: Giuseppe Querques, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Ospedale San Raffaele
name: Riccardo Sacconi, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Ospedale San Raffaele
name: Francesco Gelormini, MDs
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.
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.
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.
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.