OCT and OCT-Angiography Biomarkers of Treatment Response to Dexamethasone Implant in Macular Edema Due to Retinal Vascular Diseases - DME and RVO

NCT06332690 | Recruiting

• 1 other identifier: 514.2021
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this pilot study is to evaluate different imaging parameters in patients with previously treatment-naive DME and ME due to RVO before and after treatment with dexamethasone implant, in order to find specific retinal inflammatory and microvascular biomarkers that may be predictive of treatment outcome.

Conditions

Diabetic Macular Edema; Macular Edema Due to Diabetes Mellitus; Retinal Vein Occlusion

Keywords

Diabetic macular edema; macular edema due to retinal vein occlusion; diabetes mellitus; retinal imaging

Outcome Measures

Primary Outcomes (1)

• Modification of inflammatory biomarkers on OCT and perfusion density parameters on OCT-A at 4 months after surgery (Change measure)

  Evaluate different inflammatory and microvascular parameters on imaging exams (OCT-A, OCT, and FAF) in patients with DME and ME secondary to RVO before and after treatment with intravitreal Dexamethasone implant, in order to identify specific predictive (imaging) biomarkers of treatment. If a new surgery is required at 4 months, an additional follow-up will be scheduled 4 months after the second surgery

  pre-surgery and at 4 months after each surgery (if applicable)

Secondary Outcomes (1)

• Initial clinical characteristics in patients with a gain in BCVA (Best Corrected Visual Acuity) of ≥ 5, ≥ 10, and ≥ 15 ETDRS (Early Treatment Diabetic Retinopathy Study) letters.

  pre-surgery and up to every 2 months

Interventions

dexamethasone implant DEVICE

Intravitreal dexamethasone implant (Dex) slowly releases steroids into the vitreous over a period of up to 6 months. Dex 0.7 mg (Ozurdex™; Allergan, Irvine, CA, USA) has been used to reduce ME in patients with DR and RVO and its efficacy in terms of best corrected visual acuity (BCVA) improvement and central macular thickness (CMT) reduction has been demonstrated in many different studies.

Eligibility Criteria

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

Study Population

Patients indicated for intravitreal Dexamethasone implantation for diabetic macular edema and retinal vein occlusion.

You may qualify if:

• previously untreated centre-involving DME or ME secondary to RVO with CMT ≥ 300 μm;
• pseudophakic eyes or eyes with a transparent lens or only initial sclerosis of the lens, in order to obtain good quality retinal imaging
• patient agreement to participate in the study.

You may not qualify if:

• any retinal disease other than DR or RVO;
• a positive history of retinal surgery and/or any other macular/retinal treatment (laser, intravitreal injections of anti-VEGF and/or steroids);
• cataract surgery within 6 months in the study eye;
• refractive error \> +/- 4D;
• Advanced glaucoma
• neurodegenerative diseases (e.g. multiple sclerosis, Alzheimer disease, Parkinson disease, etc.)
• poor quality of OCT and/or OCT-A images due to significant media opacity or poor patient cooperation.
• Ocular or periocular infections (including most viral diseases of the cornea and conjunctiva, including active epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, varicella, mycobacterial infections, and fungal diseases
• Non-intact posterior lens capsule
• Hypersensitivity to any component of the product

Sponsors & Collaborators

• IRCCS Multimedica: lead
• AbbVie: collaborator

Study Sites (1)

MultiMedica IRCCS Multimedica

Milan, 20123, Italy

RECRUITING

Related Publications (15)

• Vujosevic S, Simo R. Local and Systemic Inflammatory Biomarkers of Diabetic Retinopathy: An Integrative Approach. Invest Ophthalmol Vis Sci. 2017 May 1;58(6):BIO68-BIO75. doi: 10.1167/iovs.17-21769.

  PMID: 28510630 RESULT

• Jenkins AJ, Joglekar MV, Hardikar AA, Keech AC, O'Neal DN, Januszewski AS. Biomarkers in Diabetic Retinopathy. Rev Diabet Stud. 2015 Spring-Summer;12(1-2):159-95. doi: 10.1900/RDS.2015.12.159. Epub 2015 Aug 10.

  PMID: 26676667 RESULT

• Vujosevic S, Bini S, Torresin T, Berton M, Midena G, Parrozzani R, Martini F, Pucci P, Daniele AR, Cavarzeran F, Midena E. HYPERREFLECTIVE RETINAL SPOTS IN NORMAL AND DIABETIC EYES: B-Scan and En Face Spectral Domain Optical Coherence Tomography Evaluation. Retina. 2017 Jun;37(6):1092-1103. doi: 10.1097/IAE.0000000000001304.

  PMID: 27668929 RESULT

• Vujosevic S, Torresin T, Bini S, Convento E, Pilotto E, Parrozzani R, Midena E. Imaging retinal inflammatory biomarkers after intravitreal steroid and anti-VEGF treatment in diabetic macular oedema. Acta Ophthalmol. 2017 Aug;95(5):464-471. doi: 10.1111/aos.13294. Epub 2016 Oct 24.

  PMID: 27775223 RESULT

• McAllister IL, Vijayasekaran S, Zhang D, McLenachan S, Chen FK, Yu DY. Neuronal degeneration and associated alterations in cytokine and protein in an experimental branch retinal venous occlusion model. Exp Eye Res. 2018 Sep;174:133-146. doi: 10.1016/j.exer.2018.05.025. Epub 2018 May 24.

  PMID: 29803555 RESULT

• Boyer DS, Yoon YH, Belfort R Jr, Bandello F, Maturi RK, Augustin AJ, Li XY, Cui H, Hashad Y, Whitcup SM; Ozurdex MEAD Study Group. Three-year, randomized, sham-controlled trial of dexamethasone intravitreal implant in patients with diabetic macular edema. Ophthalmology. 2014 Oct;121(10):1904-14. doi: 10.1016/j.ophtha.2014.04.024. Epub 2014 Jun 4.

  PMID: 24907062 RESULT

• Callanan DG, Gupta S, Boyer DS, Ciulla TA, Singer MA, Kuppermann BD, Liu CC, Li XY, Hollander DA, Schiffman RM, Whitcup SM; Ozurdex PLACID Study Group. Dexamethasone intravitreal implant in combination with laser photocoagulation for the treatment of diffuse diabetic macular edema. Ophthalmology. 2013 Sep;120(9):1843-51. doi: 10.1016/j.ophtha.2013.02.018. Epub 2013 May 22.

  PMID: 23706947 RESULT

• Haller JA, Bandello F, Belfort R Jr, Blumenkranz MS, Gillies M, Heier J, Loewenstein A, Yoon YH, Jiao J, Li XY, Whitcup SM; Ozurdex GENEVA Study Group; Li J. Dexamethasone intravitreal implant in patients with macular edema related to branch or central retinal vein occlusion twelve-month study results. Ophthalmology. 2011 Dec;118(12):2453-60. doi: 10.1016/j.ophtha.2011.05.014. Epub 2011 Jul 20.

  PMID: 21764136 RESULT

• Querques L, Querques G, Lattanzio R, Gigante SR, Del Turco C, Corradetti G, Cascavilla ML, Bandello F. Repeated intravitreal dexamethasone implant (Ozurdex(R)) for retinal vein occlusion. Ophthalmologica. 2013;229(1):21-5. doi: 10.1159/000342160. Epub 2012 Sep 19.

  PMID: 23006995 RESULT

• Chang-Lin JE, Attar M, Acheampong AA, Robinson MR, Whitcup SM, Kuppermann BD, Welty D. Pharmacokinetics and pharmacodynamics of a sustained-release dexamethasone intravitreal implant. Invest Ophthalmol Vis Sci. 2011 Jan 5;52(1):80-6. doi: 10.1167/iovs.10-5285.

  PMID: 20702826 RESULT

• Otani T, Kishi S, Maruyama Y. Patterns of diabetic macular edema with optical coherence tomography. Am J Ophthalmol. 1999 Jun;127(6):688-93. doi: 10.1016/s0002-9394(99)00033-1.

  PMID: 10372879 RESULT

• Gaucher D, Sebah C, Erginay A, Haouchine B, Tadayoni R, Gaudric A, Massin P. Optical coherence tomography features during the evolution of serous retinal detachment in patients with diabetic macular edema. Am J Ophthalmol. 2008 Feb;145(2):289-296. doi: 10.1016/j.ajo.2007.09.029. Epub 2007 Dec 11.

  PMID: 18054885 RESULT

• Catier A, Tadayoni R, Paques M, Erginay A, Haouchine B, Gaudric A, Massin P. Characterization of macular edema from various etiologies by optical coherence tomography. Am J Ophthalmol. 2005 Aug;140(2):200-6. doi: 10.1016/j.ajo.2005.02.053.

  PMID: 15992752 RESULT

• Ozdemir H, Karacorlu M, Karacorlu S. Serous macular detachment in diabetic cystoid macular oedema. Acta Ophthalmol Scand. 2005 Feb;83(1):63-6. doi: 10.1111/j.1600-0420.2005.00387.x.

  PMID: 15715559 RESULT

• Vujosevic S, Bini S, Midena G, Berton M, Pilotto E, Midena E. Hyperreflective intraretinal spots in diabetics without and with nonproliferative diabetic retinopathy: an in vivo study using spectral domain OCT. J Diabetes Res. 2013;2013:491835. doi: 10.1155/2013/491835. Epub 2013 Dec 9.

  PMID: 24386645 RESULT

MeSH Terms

Conditions

Retinal Vein Occlusion; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases; Venous Thrombosis; Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Stela Vujosevic, MD

  MultiMedica - IRCCS MultiMedica

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Stela Vujosevic, MD

CONTACT

+30 02 85 99 4601; stela.vujosevic@multimedica.it

Gabriele Piccoli

CONTACT

+30 02 85 99 4601; gabriele.piccoli@multimedica.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 17, 2024
• First Posted: March 27, 2024
• Study Start: October 17, 2023
• Primary Completion: June 1, 2025
• Study Completion: December 1, 2025
• Last Updated: March 27, 2024

Record last verified: 2024-03

Locations

IT (1)