Micropulsed Laser in Patients With Macular Oedema in Retinal Dystrophies

NCT05976139 | Recruiting

• 1 other identifier: Neu 01-23
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to investigate whether subthreshold treatment with micropulsed laser can be effective in resolving macular edema in patients with inherited retinal dystrophy. Visits will be performed after 1, 3, 6, 9, 12, 18, and 24 months after treatment. Laser treatment will be performed on the day of the first visit, and its repetition at subsequent visits between months 3 and 12 will be evaluated. Evaluations of treatment effects will include:

• comprehensive ophthalmologic examination
• multifocal electroretinogram
• OCT examination
• OCT-angiography examination
• retinography Primary endpoint. \- central retinal thickness, measured by OCT

Conditions

Macular Edema; Inherited Retinal Dystrophy; Laser Retinopathy

Keywords

Visual Acuity; Retinal Function; IRD; Macular Edema

Outcome Measures

Primary Outcomes (1)

• assessment of significative change in retinal oedema compared to baseline

  assessment of central retinal thickness by macular SD-OCT

  up to 24 months

Secondary Outcomes (3)

• To study changes in visual acuity between before and after treatment

  up to 24 months

• To study the retinal function in the macular area before and after treatment.

  up to 24 months

• To study the retinal perfusion of the macular area by OCT-angiography before and after treatment.

  up to 24 months

Study Arms (1)

inherited retinal dystrophies with macular oedema

EXPERIMENTAL

Laser treatment will be performed in patients with macular edema in IRD (experimental arm) who: * underwent treatment with diuretics or nutritional drainage products for 3 months and subsequent 'wash-out' of one month 17,18 and had no reduction in macular oedema, in terms of central retinal thickness, of at least 20% compared with the initial assessment * they have had an intravitreal injection of anti-VEGF or steroids, and after 3 months there is no reduction in central retinal thickness (CRT) of at least 20% compared to the initial assessment * have after 3 months a thickness reduction \<10% compared to baseline assessment, following initial treatment with micropulsed laser, and may be candidates for repeating treatment; * are not eligible for diuretic therapy due to the presence of comorbidities.

Device: subthreshold treatment with micropulsed laser

Interventions

subthreshold treatment with micropulsed laser DEVICE

The laser instrument used is the Q 577® Laser System, Iridex, wavelength 577 yellow. The standard pattern used is: * Power: 5% Duty Cycle * Power 250 mw * Pulse duration 200 ms * Spot size 100 micron * Pattern spacing 0.0 confluente, griglie 7x7

inherited retinal dystrophies with macular oedema

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with inherited retinal disease
• Age between 18 and 80 years
• Conclusive molecular genetic study for IRD
• Male or female patient
• Presence of macular oedema assessed by sd-OCT with reduction ≤ 20% after 3 months of diuretics or draining supplements or 4 months after last anti-VEGF or steroid injection
• Phakic and pseudophakic patients
• Central Retinal thickness \> 320 microns in men and \> 305 microns in women
• Informed consent freely granted and acquired before the start of the study
• Participant has the ability to understand and willingness to follow study instructions and is likely to complete all required visits and procedures.

You may not qualify if:

• Patients with cataract extraction prior to 6 months
• Patients with IOP ≥ 20 mmHg
• Patients with a clinical diagnosis of retinal dystrophy of unproven genetic origin
• Patients with diabetes
• Patients with central serous chorioretinosis, retinal vein occlusion, age-related degeneration
• Patients with current or previous vitreo-retinal pathology or with indication for vitreo-retinal surgical therapy (tractional oedema)
• Patients with a lack of target fixation at 32 cm
• Pregnant women

Sponsors & Collaborators

• Fondazione G.B. Bietti, IRCCS: lead

Study Sites (1)

IRCSS Fondazione G:B:Bietti

Rome, RM, 00194, Italy

RECRUITING

Related Publications (15)

• Olivares-Gonzalez L, Velasco S, Campillo I, Rodrigo R. Retinal Inflammation, Cell Death and Inherited Retinal Dystrophies. Int J Mol Sci. 2021 Feb 20;22(4):2096. doi: 10.3390/ijms22042096.

  PMID: 33672611 BACKGROUND

• Bakthavatchalam M, Lai FHP, Rong SS, Ng DS, Brelen ME. Treatment of cystoid macular edema secondary to retinitis pigmentosa: a systematic review. Surv Ophthalmol. 2018 May-Jun;63(3):329-339. doi: 10.1016/j.survophthal.2017.09.009. Epub 2017 Oct 5.

  PMID: 28987613 BACKGROUND

• Hong Y, Li H, Sun Y, Ji Y. A Review of Complicated Cataract in Retinitis Pigmentosa: Pathogenesis and Cataract Surgery. J Ophthalmol. 2020 Dec 21;2020:6699103. doi: 10.1155/2020/6699103. eCollection 2020.

  PMID: 33489339 BACKGROUND

• Ikeda Y, Yoshida N, Murakami Y, Nakatake S, Notomi S, Hisatomi T, Enaida H, Ishibashi T. Long-term Surgical Outcomes of Epiretinal Membrane in Patients with Retinitis Pigmentosa. Sci Rep. 2015 Aug 13;5:13078. doi: 10.1038/srep13078.

  PMID: 26268934 BACKGROUND

• Sahel J, Bonnel S, Mrejen S, Paques M. Retinitis pigmentosa and other dystrophies. Dev Ophthalmol. 2010;47:160-167. doi: 10.1159/000320079. Epub 2010 Aug 10.

  PMID: 20703049 BACKGROUND

• Lemos Reis RF, Moreira-Goncalves N, Estrela Silva SE, Brandao EM, Falcao-Reis FM. Comparison of topical dorzolamide and ketorolac treatment for cystoid macular edema in retinitis pigmentosa and Usher's syndrome. Ophthalmologica. 2015;233(1):43-50. doi: 10.1159/000368052. Epub 2014 Nov 26.

  PMID: 25428176 BACKGROUND

• Orzalesi N, Pierrottet C, Porta A, Aschero M. Long-term treatment of retinitis pigmentosa with acetazolamide. A pilot study. Graefes Arch Clin Exp Ophthalmol. 1993 May;231(5):254-6. doi: 10.1007/BF00919100.

  PMID: 8319913 BACKGROUND

• Moore SM, Chao DL. Application of subthreshold laser therapy in retinal diseases: a review. Expert Rev Ophthalmol. 2018;13(6):311-320. doi: 10.1080/17469899.2018.1555035. Epub 2018 Dec 11.

  PMID: 31692951 BACKGROUND

• Franklin TB, Krueger-Naug AM, Clarke DB, Arrigo AP, Currie RW. The role of heat shock proteins Hsp70 and Hsp27 in cellular protection of the central nervous system. Int J Hyperthermia. 2005 Aug;21(5):379-92. doi: 10.1080/02656730500069955.

  PMID: 16048836 BACKGROUND

• Caballero S, Kent DL, Sengupta N, Li Calzi S, Shaw L, Beli E, Moldovan L, Dominguez JM 2nd, Moorthy RS, Grant MB. Bone Marrow-Derived Cell Recruitment to the Neurosensory Retina and Retinal Pigment Epithelial Cell Layer Following Subthreshold Retinal Phototherapy. Invest Ophthalmol Vis Sci. 2017 Oct 1;58(12):5164-5176. doi: 10.1167/iovs.16-20736.

  PMID: 29049716 BACKGROUND

• Chidlow G, Shibeeb O, Plunkett M, Casson RJ, Wood JP. Glial cell and inflammatory responses to retinal laser treatment: comparison of a conventional photocoagulator and a novel, 3-nanosecond pulse laser. Invest Ophthalmol Vis Sci. 2013 Mar 28;54(3):2319-32. doi: 10.1167/iovs.12-11204.

  PMID: 23439603 BACKGROUND

• Flaxel C, Bradle J, Acott T, Samples JR. Retinal pigment epithelium produces matrix metalloproteinases after laser treatment. Retina. 2007 Jun;27(5):629-34. doi: 10.1097/01.iae.0000249561.02567.fd.

  PMID: 17558327 BACKGROUND

• Chalam KV, Bressler SB, Edwards AR, Berger BB, Bressler NM, Glassman AR, Grover S, Gupta SK, Nielsen JS; Diabetic Retinopathy Clinical Research Network. Retinal thickness in people with diabetes and minimal or no diabetic retinopathy: Heidelberg Spectralis optical coherence tomography. Invest Ophthalmol Vis Sci. 2012 Dec 13;53(13):8154-61. doi: 10.1167/iovs.12-10290.

  PMID: 23132803 BACKGROUND

• Elman MJ, Bressler NM, Qin H, Beck RW, Ferris FL 3rd, Friedman SM, Glassman AR, Scott IU, Stockdale CR, Sun JK; Diabetic Retinopathy Clinical Research Network. Expanded 2-year follow-up of ranibizumab plus prompt or deferred laser or triamcinolone plus prompt laser for diabetic macular edema. Ophthalmology. 2011 Apr;118(4):609-14. doi: 10.1016/j.ophtha.2010.12.033.

  PMID: 21459214 BACKGROUND

• Marashi A, Zazo A. Hybrid threshold laser to treat diabetic macular edema: A retrospective analysis single center cohort study. Ann Med Surg (Lond). 2022 Jul 31;80:104222. doi: 10.1016/j.amsu.2022.104222. eCollection 2022 Aug.

  PMID: 36045820 BACKGROUND

Related Links

• Hereditary Retinal Degenerations and Cystoid Macular Edema
• Photothermal Stimulation with a Micropulse Laser
• Retinal Distrophies

MeSH Terms

Conditions

Macular Edema

Condition Hierarchy (Ancestors)

Macular Degeneration; Retinal Degeneration; Retinal Diseases; Eye Diseases

Study Officials

• Lucia Ziccardi, MD, PhD

  IRCCS Fondazione G.B. Bietti

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lucia Ziccardi, MD, PhD

CONTACT

+390684009486; neuger@fondazionebietti.it

Federica Petrocchi, Orthoptist

CONTACT

+390684009486; neuger@fondazionebietti.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: no masking
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 19, 2023
• First Posted: August 4, 2023
• Study Start: September 6, 2023
• Primary Completion: July 30, 2025
• Study Completion: July 30, 2025
• Last Updated: February 28, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• Time Frame: Six months after the end of the study
• Access Criteria: On demand

Locations

IT (1)