Retinal NeuropathyNCT04808804
Retinal Neurodegeneration In Type 2 Diabetes Mellitus Detected by Optical Coherence Tomography
An observational study of Retinal Neuropathy and Neurodegeneration, run by Assiut University.
Trial summary
Evaluation of retinal neurodegeneration in patients with type 2 diabetes mellitus (DM2) without diabetic retinopathy or with mild non proliferative diabetic retinopathy Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Retinal Neuropathy, Neurodegeneration
- What is being tested?
- Optical Coherence Tomography (OCT)
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- Jun 2021to Jun 2022
- 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 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 40 eyes of patients with DM2 and without any signs of diabetic retinopathy or with mild non proliferative diabetic retinopathy and 40 eyes of healthy controls
Who may be able to join
- All patients with confirmed type 2 DM diagnosis of at least 6 months
- Best-corrected visual acuity (BCVA) of 6/12 or higher (using a Snellen chart) in each eye
- Intraocular pressure (by applanation) less than 21 mmHg.
- Healthy controls had no record nor evidence of ocular or neurologic disease of any kind; their BCVA is > 6/9 based on the Snellen scale.
Who cannot join
- presence or past history of moderate or severe non proliferative diabetic retinopathy or proliferative diabetic retinopathy , confirmed by indirect funduscopy or retinography images.
- presence of significant refractive errors (≥5 diopters of spherical equivalent refraction or 3 diopters of astigmatism)
- intraocular pressure ≥21 mmHg
- media opacifications
- concomitant ocular diseases, including history of glaucoma or retinal pathology
- systemic conditions that could affect the visual system, including neurodegenerative disorders such as Parkinson's disease, multiple sclerosis, or dementia.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Retinal Neurodegeneration In Patients With Type 2 Diabetes Mellitus Without Diabetic Retinopathy or With Mild Non Proliferative Diabetic Retinopathy Detected by Optical Coherence Tomography
Evaluation of retinal neurodegeneration in patients with type 2 diabetes mellitus (DM2) without diabetic retinopathy or with mild non proliferative diabetic retinopathy
Read the detailed description
Retinal complications in diabetes mellitus (DM) patients were typically considered part of a vascular process. However, recent studies suggest that ocular degeneration in DM might be caused by 2 different conditions: vasculopathy and neuropathy . For some authors, neuropathy observed in the retina of DM patients might be a part of an underlying polyneuropathy ; for others, however, neuropathic changes might precede microvascular alterations .
Axons of retinal ganglion cells compose the retinal nerve fiber layer (RNFL) in the retina and then form the optic nerve connecting the eyeball and brain. Retinal nerve fiber layer (RNFL) loss is recognized as an important neurodegenerative sign in glaucoma. Thinning of the RNFL has also been found in multiple sclerosis, Parkinson's disease and Alzheimer's disease, indicating neurodegeneration of the retina. If RNFL thinning is significant in diabetic patients with preclinical diabetic retinopathy, evaluation of peripapillary RNFL thickness would be very important, because early detection and treatment of diabetic retinopathy is critical to reduce the risk of blindness Optical coherence tomography (OCT) has been introduced into clinical practice as the most noninvasive and objective method to visualize the retina, showing an amount of detail that resembles histological specimens. Initially, OCT was applied to detect complications of DR (edema macular or epiretinal membrane). Later on, it allowed quantitative and qualitative measurements of retinal thickness and segmentation of all intraretinal layers. OCT might detect early retinal neurodegenerative changes, and thus help define which diabetic patients may be at risk to develop DR.
- Conditions
- Retinal Neuropathy, Neurodegeneration
- Being tested
- Optical Coherence Tomography (OCT)
- Medical subject headings
- Nerve Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Optical Coherence Tomography (OCT)Diagnostic test
a noninvasive imaging technology used to obtain high resolution cross-sectional images of the retina
| Study group | Role | What they receive |
|---|---|---|
| DM | Patients With Type 2 Diabetes Mellitus without any signs of diabetic retinopathy or with mild non proliferative diabetic retinopathy Receives: Diagnostic Test: Optical Coherence Tomography (OCT) | |
| Healthy | healthy controls Receives: Diagnostic Test: Optical Coherence Tomography (OCT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
RNFL thickness
retinal nerve fiber layer (RNFL) will be evaluated
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2021
- Study startJun 2021 (estimated)
- Primary completionMar 2022 (estimated)
- Study completionJun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Retinal NeuropathyStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emel Saad Tawadrous, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04808804
- Sponsor's protocol ID
- Neurodegeneration In DM
- Status last verified
- Mar 2021
- First submitted
- 18 Mar 2021
- Last updated
- 23 Mar 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Santos AR, Ribeiro L, Bandello F, Lattanzio R, Egan C, Frydkjaer-Olsen U, Garcia-Arumi J, Gibson J, Grauslund J, Harding SP, Lang GE, Massin P, Midena E, Scanlon P, Aldington SJ, Simao S, Schwartz C, Ponsati B, Porta M, Costa MA, Hernandez C, Cunha-Vaz J, Simo R; European Consortium for the Early Treatment of Diabetic Retinopathy (EUROCONDOR). Functional and Structural Findings of Neurodegeneration in Early Stages of Diabetic Retinopathy: Cross-sectional Analyses of Baseline Data of the EUROCONDOR Project. Diabetes. 2017 Sep;66(9):2503-2510. doi: 10.2337/db16-1453. Epub 2017 Jun 29.
PubMed 28663190Shahidi AM, Sampson GP, Pritchard N, Edwards K, Vagenas D, Russell AW, Malik RA, Efron N. Retinal nerve fibre layer thinning associated with diabetic peripheral neuropathy. Diabet Med. 2012 Jul;29(7):e106-11. doi: 10.1111/j.1464-5491.2012.03588.x.
PubMed 22269030Salvi L, Plateroti P, Balducci S, Bollanti L, Conti FG, Vitale M, Recupero SM, Enrici MM, Fenicia V, Pugliese G. Abnormalities of retinal ganglion cell complex at optical coherence tomography in patients with type 2 diabetes: a sign of diabetic polyneuropathy, not retinopathy. J Diabetes Complications. 2016 Apr;30(3):469-76. doi: 10.1016/j.jdiacomp.2015.12.025. Epub 2015 Dec 30.
PubMed 26809902Simo R, Hernandez C; European Consortium for the Early Treatment of Diabetic Retinopathy (EUROCONDOR). Neurodegeneration in the diabetic eye: new insights and therapeutic perspectives. Trends Endocrinol Metab. 2014 Jan;25(1):23-33. doi: 10.1016/j.tem.2013.09.005. Epub 2013 Nov 1.
PubMed 24183659Zangwill LM, Bowd C. Retinal nerve fiber layer analysis in the diagnosis of glaucoma. Curr Opin Ophthalmol. 2006 Apr;17(2):120-31. doi: 10.1097/01.icu.0000193079.55240.18.
PubMed 16552246Petzold A, de Boer JF, Schippling S, Vermersch P, Kardon R, Green A, Calabresi PA, Polman C. Optical coherence tomography in multiple sclerosis: a systematic review and meta-analysis. Lancet Neurol. 2010 Sep;9(9):921-32. doi: 10.1016/S1474-4422(10)70168-X.
PubMed 20723847Satue M, Garcia-Martin E, Fuertes I, Otin S, Alarcia R, Herrero R, Bambo MP, Pablo LE, Fernandez FJ. Use of Fourier-domain OCT to detect retinal nerve fiber layer degeneration in Parkinson's disease patients. Eye (Lond). 2013 Apr;27(4):507-14. doi: 10.1038/eye.2013.4. Epub 2013 Feb 22.
PubMed 23429414Marziani E, Pomati S, Ramolfo P, Cigada M, Giani A, Mariani C, Staurenghi G. Evaluation of retinal nerve fiber layer and ganglion cell layer thickness in Alzheimer's disease using spectral-domain optical coherence tomography. Invest Ophthalmol Vis Sci. 2013 Sep 5;54(9):5953-8. doi: 10.1167/iovs.13-12046.
PubMed 23920375Photocoagulation for diabetic macular edema. Early Treatment Diabetic Retinopathy Study report number 1. Early Treatment Diabetic Retinopathy Study research group. Arch Ophthalmol. 1985 Dec;103(12):1796-806.
PubMed 2866759van Dijk HW, Verbraak FD, Stehouwer M, Kok PH, Garvin MK, Sonka M, DeVries JH, Schlingemann RO, Abramoff MD. Association of visual function and ganglion cell layer thickness in patients with diabetes mellitus type 1 and no or minimal diabetic retinopathy. Vision Res. 2011 Jan 28;51(2):224-8. doi: 10.1016/j.visres.2010.08.024. Epub 2010 Aug 27.
PubMed 20801146Fischer MD, Huber G, Beck SC, Tanimoto N, Muehlfriedel R, Fahl E, Grimm C, Wenzel A, Reme CE, van de Pavert SA, Wijnholds J, Pacal M, Bremner R, Seeliger MW. Noninvasive, in vivo assessment of mouse retinal structure using optical coherence tomography. PLoS One. 2009 Oct 19;4(10):e7507. doi: 10.1371/journal.pone.0007507.
PubMed 19838301Ceklic L, Maar N, Neubauer AS. Optical coherence tomography fast versus regular macular thickness mapping in diabetic retinopathy. Ophthalmic Res. 2008;40(5):235-40. doi: 10.1159/000127830. Epub 2008 Apr 25.
PubMed 18437033Wilkinson CP, Ferris FL 3rd, Klein RE, Lee PP, Agardh CD, Davis M, Dills D, Kampik A, Pararajasegaram R, Verdaguer JT; Global Diabetic Retinopathy Project Group. Proposed international clinical diabetic retinopathy and diabetic macular edema disease severity scales. Ophthalmology. 2003 Sep;110(9):1677-82. doi: 10.1016/S0161-6420(03)00475-5.
PubMed 13129861
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retinal Neurodegeneration In Patients With Type 2 Diabetes Mellitus Without Diabetic Retinopathy or With Mild Non Proliferative Diabetic Retinopathy Detected by Optical Coherence Tomography
- ClinicalTrials.gov ID
- NCT04808804
- Acronym / sponsor ID
- Neurodegeneration In DM
- Conditions
- Retinal Neuropathy, Neurodegeneration
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Jun 2021 (estimated)
- Primary completion
- Mar 2022 (estimated)
- Study completion
- Jun 2022 (estimated)
- First posted
- 22 Mar 2021 (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.
Evaluation of retinal neurodegeneration in patients with type 2 diabetes mellitus (DM2) without diabetic retinopathy or with mild non proliferative diabetic retinopathy
Detailed description
Retinal complications in diabetes mellitus (DM) patients were typically considered part of a vascular process. However, recent studies suggest that ocular degeneration in DM might be caused by 2 different conditions: vasculopathy and neuropathy . For some authors, neuropathy observed in the retina of DM patients might be a part of an underlying polyneuropathy ; for others, however, neuropathic changes might precede microvascular alterations .
Axons of retinal ganglion cells compose the retinal nerve fiber layer (RNFL) in the retina and then form the optic nerve connecting the eyeball and brain. Retinal nerve fiber layer (RNFL) loss is recognized as an important neurodegenerative sign in glaucoma. Thinning of the RNFL has also been found in multiple sclerosis, Parkinson's disease and Alzheimer's disease, indicating neurodegeneration of the retina. If RNFL thinning is significant in diabetic patients with preclinical diabetic retinopathy, evaluation of peripapillary RNFL thickness would be very important, because early detection and treatment of diabetic retinopathy is critical to reduce the risk of blindness Optical coherence tomography (OCT) has been introduced into clinical practice as the most noninvasive and objective method to visualize the retina, showing an amount of detail that resembles histological specimens. Initially, OCT was applied to detect complications of DR (edema macular or epiretinal membrane). Later on, it allowed quantitative and qualitative measurements of retinal thickness and segmentation of all intraretinal layers. OCT might detect early retinal neurodegenerative changes, and thus help define which diabetic patients may be at risk to develop DR.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DM | – | Diagnostic Test: Optical Coherence Tomography (OCT)Patients With Type 2 Diabetes Mellitus without any signs of diabetic retinopathy or with mild non proliferative diabetic retinopathy |
| Healthy | – | Diagnostic Test: Optical Coherence Tomography (OCT)healthy controls |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 40 eyes of patients with DM2 and without any signs of diabetic retinopathy or with mild non proliferative diabetic retinopathy and 40 eyes of healthy controls
Key inclusion criteria (4 listed)
- All patients with confirmed type 2 DM diagnosis of at least 6 months
- Best-corrected visual acuity (BCVA) of 6/12 or higher (using a Snellen chart) in each eye
- Intraocular pressure (by applanation) less than 21 mmHg.
- Healthy controls had no record nor evidence of ocular or neurologic disease of any kind; their BCVA is > 6/9 based on the Snellen scale.
Key exclusion criteria (6 listed)
- presence or past history of moderate or severe non proliferative diabetic retinopathy or proliferative diabetic retinopathy , confirmed by indirect funduscopy or retinography images.
- presence of significant refractive errors (≥5 diopters of spherical equivalent refraction or 3 diopters of astigmatism)
- intraocular pressure ≥21 mmHg
- media opacifications
- concomitant ocular diseases, including history of glaucoma or retinal pathology
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 |
|---|---|---|
| Optical Coherence Tomography (OCT)a noninvasive imaging technology used to obtain high resolution cross-sectional images of the retina | Diagnostic test | DM, Healthy |
Primary outcome
RNFL thickness
Time frame: Baseline
retinal nerve fiber layer (RNFL) will be evaluated
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2021.
- Background: PubMed 28663190Santos AR, Ribeiro L, Bandello F, Lattanzio R, Egan C, Frydkjaer-Olsen U, Garcia-Arumi J, Gibson J, Grauslund J, Harding SP, Lang GE, Massin P, Midena E, Scanlon P, Aldington SJ, Simao S, Schwartz C, Ponsati B, Porta M, Costa MA, Hernandez C, Cunha-Vaz J, Simo R; European Consortium for the Early Treatment of Diabetic Retinopathy (EUROCONDOR). Functional and Structural Findings of Neurodegeneration in Early Stages of Diabetic Retinopathy: Cross-sectional Analyses of Baseline Data of the EUROCONDOR Project. Diabetes. 2017 Sep;66(9):2503-2510. doi: 10.2337/db16-1453. Epub 2017 Jun 29.
- Background: PubMed 22269030Shahidi AM, Sampson GP, Pritchard N, Edwards K, Vagenas D, Russell AW, Malik RA, Efron N. Retinal nerve fibre layer thinning associated with diabetic peripheral neuropathy. Diabet Med. 2012 Jul;29(7):e106-11. doi: 10.1111/j.1464-5491.2012.03588.x.
- Background: PubMed 26809902Salvi L, Plateroti P, Balducci S, Bollanti L, Conti FG, Vitale M, Recupero SM, Enrici MM, Fenicia V, Pugliese G. Abnormalities of retinal ganglion cell complex at optical coherence tomography in patients with type 2 diabetes: a sign of diabetic polyneuropathy, not retinopathy. J Diabetes Complications. 2016 Apr;30(3):469-76. doi: 10.1016/j.jdiacomp.2015.12.025. Epub 2015 Dec 30.
- Background: PubMed 24183659Simo R, Hernandez C; European Consortium for the Early Treatment of Diabetic Retinopathy (EUROCONDOR). Neurodegeneration in the diabetic eye: new insights and therapeutic perspectives. Trends Endocrinol Metab. 2014 Jan;25(1):23-33. doi: 10.1016/j.tem.2013.09.005. Epub 2013 Nov 1.
- Background: PubMed 16552246Zangwill LM, Bowd C. Retinal nerve fiber layer analysis in the diagnosis of glaucoma. Curr Opin Ophthalmol. 2006 Apr;17(2):120-31. doi: 10.1097/01.icu.0000193079.55240.18.
- Background: PubMed 20723847Petzold A, de Boer JF, Schippling S, Vermersch P, Kardon R, Green A, Calabresi PA, Polman C. Optical coherence tomography in multiple sclerosis: a systematic review and meta-analysis. Lancet Neurol. 2010 Sep;9(9):921-32. doi: 10.1016/S1474-4422(10)70168-X.
- Background: PubMed 23429414Satue M, Garcia-Martin E, Fuertes I, Otin S, Alarcia R, Herrero R, Bambo MP, Pablo LE, Fernandez FJ. Use of Fourier-domain OCT to detect retinal nerve fiber layer degeneration in Parkinson's disease patients. Eye (Lond). 2013 Apr;27(4):507-14. doi: 10.1038/eye.2013.4. Epub 2013 Feb 22.
- Background: PubMed 23920375Marziani E, Pomati S, Ramolfo P, Cigada M, Giani A, Mariani C, Staurenghi G. Evaluation of retinal nerve fiber layer and ganglion cell layer thickness in Alzheimer's disease using spectral-domain optical coherence tomography. Invest Ophthalmol Vis Sci. 2013 Sep 5;54(9):5953-8. doi: 10.1167/iovs.13-12046.
- Background: PubMed 2866759Photocoagulation for diabetic macular edema. Early Treatment Diabetic Retinopathy Study report number 1. Early Treatment Diabetic Retinopathy Study research group. Arch Ophthalmol. 1985 Dec;103(12):1796-806.
- Background: PubMed 20801146van Dijk HW, Verbraak FD, Stehouwer M, Kok PH, Garvin MK, Sonka M, DeVries JH, Schlingemann RO, Abramoff MD. Association of visual function and ganglion cell layer thickness in patients with diabetes mellitus type 1 and no or minimal diabetic retinopathy. Vision Res. 2011 Jan 28;51(2):224-8. doi: 10.1016/j.visres.2010.08.024. Epub 2010 Aug 27.
- Background: PubMed 19838301Fischer MD, Huber G, Beck SC, Tanimoto N, Muehlfriedel R, Fahl E, Grimm C, Wenzel A, Reme CE, van de Pavert SA, Wijnholds J, Pacal M, Bremner R, Seeliger MW. Noninvasive, in vivo assessment of mouse retinal structure using optical coherence tomography. PLoS One. 2009 Oct 19;4(10):e7507. doi: 10.1371/journal.pone.0007507.
- Background: PubMed 18437033Ceklic L, Maar N, Neubauer AS. Optical coherence tomography fast versus regular macular thickness mapping in diabetic retinopathy. Ophthalmic Res. 2008;40(5):235-40. doi: 10.1159/000127830. Epub 2008 Apr 25.
Related trials for Retinal Neuropathy
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
RecruitingPhase 1
Safety of Cultured Allogeneic Adult Umbilical Cord or Placental Derived Mesenchymal Stem Cell Exosomes for NAION
Eye Diseases, Retinitis Pigmentosa
Not yet recruitingPhase 4
Emerging Indications for Hyperbaric Oxygen Treatment
Post-COVID-19 Condition, Ulcerative Colitis
Recruiting
New Non-invasive Modalities for Assessing Retinal Structure and Function
Ischemic Optic Neuropathy, Branch Retinal Artery Occlusion
RecruitingObservational study
Global Registry and Natural History Study for Mitochondrial Disorders
Mitochondrial Diseases, Kearns-Sayre Syndrome
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.
Questions about this trial
What is this clinical trial studying?
An observational study of Retinal Neuropathy and Neurodegeneration, run by Assiut University.
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 4 inclusion and 6 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 23 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
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 Emel Saad Tawadrous, MBBCh (+201284854021, emelsaad@ymail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
RNFL thickness (time frame: Baseline). 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 NCT04808804, which also lists 13 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 23 Mar 2021.