Diabetic Macular EdemaNCT06332690
OCT and OCT-Angiography Biomarkers of Treatment Response to Dexamethasone Implant in Macular Edema Due to Retinal Vascular Diseases - DME and RVO
An observational study of Diabetic Macular Edema and Macular Edema Due to Diabetes Mellitus, run by IRCCS Multimedica at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Macular Edema, Macular Edema Due to Diabetes Mellitus, Retinal Vein Occlusion
- What is being tested?
- dexamethasone implant
- Type of treatment
- Medical device
- How many people
- 50 participants
- Where
- 1 siteItaly
- Study dates
- 17 Oct 2023to Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients indicated for intravitreal Dexamethasone implantation for diabetic macular edema and retinal vein occlusion.
Who may be able to join
- 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.
Who cannot join
- 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.)
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
MultiMedica IRCCS Multimedica
Milan, 20123
Stela Vujosevic, MD, +39 02 85 99 4601, stela.vujosevic@multimedica.it
GAbriele Piccoli, +39 02 85 99 4601, gabriele.piccoli@multimedica.it
About this study
Official title: Imaging Biomarkers of Treatment Response to Dexamethasone Implant in Macular Edema Due to Retinal Vascular Diseases - Diabetic Macular Edema and Retinal Vein Occlusion.
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.
Read the detailed description
Diabetic retinopathy (DR) and retinal vein occlusion (RVO) are complex multifactorial diseases and the leading causes of visual impairment worldwide. The exact mechanisms leading to Macular Edema (ME) in DR and RVO are not fully understood, actual evidence focuses on the role of inflammation as critical contributing factor in ME pathogenesis and several studies described the association between high levels of systemic and local inflammatory molecules and the development of ME. Even if vascular endothelial growth factor (VEGF) is the most studied factor involved in ME pathogenesis in retinal vascular diseases and the main target of available therapeutic strategies, its role cannot explain alone all the events taking place in the onset and progression of these diseases. VEGF selective inhibition is not sufficient to stop the inflammatory cascade in DR and RVO and anti-VEGF therapies are frequently of transient benefit, especially in DME treatment, needing repeated injections over time and suggesting the involvement of other molecular pathways. Intravitreal corticosteroids block the production of inflammatory mediators (including VEGF) and inhibit leukostasis. In particular, dexamethasone has the highest relative clinical efficacy of any corticosteroid applied to ophthalmology practice. 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. Thanks to the great advances in retinal imaging technologies of the last years, a new concept of non-invasive "imaging biomarker" of retinal inflammation has emerged and has made its way in the study of patients with DR and RVO. Clinical research has consequently developed great interest in finding specific retinal inflammatory parameters in DR and RVO and there is a growing body of scientific evidence on the importance of this topic. Moreover, the evaluation of these inflammatory biomarkers might be helpful in the prediction of treatment response. Nowadays, main proposed imaging biomarkers of inflammation include subfoveal neuroretinal detachment (SND) and hyperreflective retinal spots (HRS), visible on optical coherence tomography (OCT). SND consists in extracellular fluid accumulation between the outer segments of photoreceptors and the retinal pigment epithelium and is present in approximately 15-30% of eyes with DME and in an even greater number of patients with ME secondary to RVO. The presence of SND has been associated with higher levels of local inflammatory molecules, in particular IL-6. HRS are increased in number in patients with diabetes (with or without DR) and RVO; they have specific characteristics and are thought to represent aggregates of activated microglial cells that progressively migrate from the inner to the outer retina, confirming their role as inflammatory biomarkers. 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. The novelty of this study is a detailed evaluation of multimodal imaging modifications in DME and ME due to RVO after treatment with Dex in order to document its anti-inflammatory effect.
- Being tested
- dexamethasone implant
- Keywords
- Diabetic macular edema, macular edema due to retinal vein occlusion, diabetes mellitus, retinal imaging
- Medical subject headings
- Retinal Vein Occlusion, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dexamethasone implantDevice
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Evaluate different inflammatory and microvascular parameters on imaging exams (OCT, OCT-A, and FAF) in patients with improvement in BCVA (≥ 5, ≥ 10, and ≥ 15 ETDRS letters) at the final visit; and in patients showing recurrence during the follow-up period.
Measured: pre-surgery and up to every 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2024
- Study start17 Oct 2023
- Primary completionJun 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Diabetic Macular EdemaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS Multimedica
- Sponsor type
- University, hospital or other
- Collaborators
- AbbVie
- Responsible party
- Sponsor
- Investigators
- Stela Vujosevic, MD, Principal investigator, MultiMedica - IRCCS MultiMedica
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06332690
- Sponsor's protocol ID
- 514.2021
- Status last verified
- Mar 2024
- First submitted
- 17 Mar 2024
- Last updated
- 27 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 28510630Jenkins 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.
PubMed 26676667Vujosevic 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.
PubMed 27668929Vujosevic 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.
PubMed 27775223McAllister 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.
PubMed 29803555Boyer 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.
PubMed 24907062Callanan 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.
PubMed 23706947Haller 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.
PubMed 21764136Querques 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.
PubMed 23006995Chang-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.
PubMed 20702826Otani 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.
PubMed 10372879Gaucher 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.
PubMed 18054885Catier 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.
PubMed 15992752Ozdemir 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.
PubMed 15715559Vujosevic 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.
PubMed 24386645
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Imaging Biomarkers of Treatment Response to Dexamethasone Implant in Macular Edema Due to Retinal Vascular Diseases - Diabetic Macular Edema and Retinal Vein Occlusion.
- ClinicalTrials.gov ID
- NCT06332690
- Acronym / sponsor ID
- 514.2021
- Keywords
- Diabetic macular edema, macular edema due to retinal vein occlusion, diabetes mellitus, retinal imaging
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- IRCCS MultimedicaUniversity, hospital or other
- Collaborators
- AbbVie
- Study start
- 17 Oct 2023 (actual)
- Primary completion
- Jun 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 27 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Diabetic retinopathy (DR) and retinal vein occlusion (RVO) are complex multifactorial diseases and the leading causes of visual impairment worldwide. The exact mechanisms leading to Macular Edema (ME) in DR and RVO are not fully understood, actual evidence focuses on the role of inflammation as critical contributing factor in ME pathogenesis and several studies described the association between high levels of systemic and local inflammatory molecules and the development of ME. Even if vascular endothelial growth factor (VEGF) is the most studied factor involved in ME pathogenesis in retinal vascular diseases and the main target of available therapeutic strategies, its role cannot explain alone all the events taking place in the onset and progression of these diseases. VEGF selective inhibition is not sufficient to stop the inflammatory cascade in DR and RVO and anti-VEGF therapies are frequently of transient benefit, especially in DME treatment, needing repeated injections over time and suggesting the involvement of other molecular pathways. Intravitreal corticosteroids block the production of inflammatory mediators (including VEGF) and inhibit leukostasis. In particular, dexamethasone has the highest relative clinical efficacy of any corticosteroid applied to ophthalmology practice. 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. Thanks to the great advances in retinal imaging technologies of the last years, a new concept of non-invasive "imaging biomarker" of retinal inflammation has emerged and has made its way in the study of patients with DR and RVO. Clinical research has consequently developed great interest in finding specific retinal inflammatory parameters in DR and RVO and there is a growing body of scientific evidence on the importance of this topic. Moreover, the evaluation of these inflammatory biomarkers might be helpful in the prediction of treatment response. Nowadays, main proposed imaging biomarkers of inflammation include subfoveal neuroretinal detachment (SND) and hyperreflective retinal spots (HRS), visible on optical coherence tomography (OCT). SND consists in extracellular fluid accumulation between the outer segments of photoreceptors and the retinal pigment epithelium and is present in approximately 15-30% of eyes with DME and in an even greater number of patients with ME secondary to RVO. The presence of SND has been associated with higher levels of local inflammatory molecules, in particular IL-6. HRS are increased in number in patients with diabetes (with or without DR) and RVO; they have specific characteristics and are thought to represent aggregates of activated microglial cells that progressively migrate from the inner to the outer retina, confirming their role as inflammatory biomarkers. 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. The novelty of this study is a detailed evaluation of multimodal imaging modifications in DME and ME due to RVO after treatment with Dex in order to document its anti-inflammatory effect.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients indicated for intravitreal Dexamethasone implantation for diabetic macular edema and retinal vein occlusion.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (10 listed)
- any retinal disease other than DR or RVO;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| dexamethasone implantIntravitreal 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. | Device | – |
Primary outcome
Modification of inflammatory biomarkers on OCT and perfusion density parameters on OCT-A at 4 months after surgery (Change measure)
Time frame: pre-surgery and at 4 months after each surgery (if applicable)
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
1 secondary outcome
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.
Time frame: pre-surgery and up to every 2 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2024.
- Results publication: PubMed 28510630Vujosevic 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.
- Results publication: PubMed 26676667Jenkins 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.
- Results publication: PubMed 27668929Vujosevic 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.
- Results publication: PubMed 27775223Vujosevic 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.
- Results publication: PubMed 29803555McAllister 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.
- Results publication: PubMed 24907062Boyer 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.
- Results publication: PubMed 23706947Callanan 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.
- Results publication: PubMed 21764136Haller 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.
- Results publication: PubMed 23006995Querques 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.
- Results publication: PubMed 20702826Chang-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.
- Results publication: PubMed 10372879Otani 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.
- Results publication: PubMed 18054885Gaucher 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stela Vujosevic, MD principal investigator
MultiMedica - IRCCS MultiMedica
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetic Macular Edema and Macular Edema Due to Diabetes Mellitus, run by IRCCS Multimedica at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Stela Vujosevic, MD (+30 02 85 99 4601, stela.vujosevic@multimedica.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Modification of inflammatory biomarkers on OCT and perfusion density parameters on OCT-A at 4 months after surgery (Change measure) (time frame: pre-surgery and at 4 months after each surgery (if applicable)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06332690, which also lists 15 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2024.