Optic NeuritisPhase 2/3NCT04942002
Retrobulbar Methylprednisolone as Adjunctive Treatment in Optic Neuritis Trial
A Phase 2/3 study testing Methylprednisolone Acetate 40 MG/ML [Depo-Medrol] in people with Optic Neuritis and Treatment, run by Asociación para Evitar la Ceguera en México at 1 site in Mexico.
Trial summary
A double-blind prospective randomized clinical trial of treatment for optic neuritis comparing visual outcome of patients treated by standard therapy (intravenous methylprednisolone) + placebo injection and standard therapy + retrobulbar methylprednisolone. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Optic Neuritis, Treatment, Methylprednisolone
- What is being tested?
- Methylprednisolone Acetate 40 MG/ML [Depo-Medrol]
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteMexico
- Study dates
- 15 Jun 2021to 15 Sep 2023
- Phase
- Phase 2/3
- 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 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Both genres
- Age between 18 and 85 years old.
- Optic neuritis diagnosis ( relative afferent pupillary defect, acquired dyschromatopsia, low vision, prechiasmatic campimetric defect)
- 1 month after symptoms started
- If is a bilateral simultaneous optic neuritis the eye with the worst vision will be included.
- if is a bilateral sequential optic neuritis the eye with lees 1 month evolution will be included.
Who cannot join
- Visual field better than 20/60 at the beginning of the study.
- History of optic neuritis in the eye under study.
- History of additional ophthalmological or neurological pathology that has caused visual loss in the eye under study.
- History of previous treatment with intravenous methylprednisolone since the onset of symptoms.
- History of high myopia.
Trial locations and contacts
1 site in 1 country.
Mexico1 site, 1 recruiting
- Recruiting
Jorge Cárdenas Belaunzarán
Mexico City, 04030
Jorge Cárdenas-Belaunzarán, MD, MSc, 5510841400 ext. 1207
About this study
Official title: Retrobulbar Methylprednisolone as Adjunctive Treatment in Optic Neuritis. Randomized Controlled Trial.
A double-blind prospective randomized clinical trial of treatment for optic neuritis comparing visual outcome of patients treated by standard therapy (intravenous methylprednisolone) + placebo injection and standard therapy + retrobulbar methylprednisolone.
Read the detailed description
A double-blind prospective randomized clinical trial of treatment for optic neuritis comparing visual outcome of patients treated by standard therapy (intravenous methylprednisolone) + placebo injection and standard therapy + retrobulbar methylprednisolone.
Enrollment: 50. Randomized groups (2)
- Standard treatment + placebo
- Standard treatment + intervention Masking: Double (participant and outcomes assessor) Participants won't be aware to which group they were assigned. Investigator in charge of assessing outcomes and analyzing data won't be aware to which group participants were assigned
- Conditions
- Optic Neuritis, Treatment, Methylprednisolone
- Being tested
- Methylprednisolone Acetate 40 MG/ML [Depo-Medrol], Placebo Comparator: Standard treatment + placebo
- Keywords
- Optic Neuritis, Methylprednisolone, Retrobulbar injection
- Medical subject headings
- Optic Neuritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Methylprednisolone Acetate 40 MG/ML [Depo-Medrol]Drug
Also called Experimental: Standard treatment + intervention
Retrobulbar injection performed by care provider
Placebo Comparator: Standard treatment + placeboDrug
Also called 1. Standard treatment + placebo
Intravenous Methylprednisolone succinate (1 g daily for 5 days) + paraocular injection of 0.9% saline solution by care provider
| Study group | Role | What they receive |
|---|---|---|
| Standard treatment + placebo | Placebo comparator | Intravenous Methylprednisolone succinate (1 g daily for 5 days) + paraocular injection of 0.9% saline solution Receives: Drug: Placebo Comparator: Standard treatment + placebo |
| Standard treatment + intervention | Experimental | Intravenous Methylprednisolone succinate (1 g daily for 5 days) + retrobulbar injection of 2 cc (40 mg/mL) to methylprednisolone acetate Receives: Drug: Methylprednisolone Acetate 40 MG/ML [Depo-Medrol] |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline Visual Capacity
Best corrected visual acuity
Measured: Initial visit, 2-week visit, 1-month visit, 3-month visit
Secondary outcomes (3)
Change from Baseline Color vision
Color vision as measured by Ishihara plates
Measured: Initial visit, 2-week visit, 1-month visit, 3-month visit
Change from Baseline Visual field defect
Visual fields as measured by Goldmann perimetry
Measured: Initial visit, 2-week visit, 1-month visit, 3-month visit
Change from Baseline Oct pRNFL (microns)
Nerve fiber thickness as measured by OCT
Measured: 2-week visit, 3-month visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2021
- Study start15 Jun 2021 (estimated)
- Primary completion15 Jun 2023 (estimated)
- Study completion15 Sep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (24)Papers the sponsor has linked to this study.
- Other trials for Optic NeuritisStudies 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
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized groups (2) 1. Standard treatment + placebo 2. Standard treatment + intervention
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Asociación para Evitar la Ceguera en México
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jorge Cárdenas-Belaunzarán, MD, MSc, Study director, Asociación Para Evitar la Ceguera en México I.A.PKaren Flores-Guevara, MD, Principal investigator, Asociación Para Evitar la Ceguera en México I.A.P
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04942002
- Sponsor's protocol ID
- Neu-21-01
- Status last verified
- Jun 2021
- First submitted
- 15 Jun 2021
- Last updated
- 28 Jun 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: This study is confidential and no information will be shared with the participants.
Publications
Yau GS, Lee JW, Lau PP, Tam VT, Wong WW, Yuen CY. Longitudinal Changes in Retinal Nerve Fibre Layer Thickness after an Isolated Unilateral Retrobulbar Optic Neuritis: 1-Year Results. Neuroophthalmology. 2015 Jan 22;39(1):22-25. doi: 10.3109/01658107.2014.984230. eCollection 2015 Feb.
PubMed 27928326Prasad S, Volpe NJ, Balcer LJ. Approach to optic neuropathies: clinical update. Neurologist. 2010 Jan;16(1):23-34. doi: 10.1097/NRL.0b013e3181be6fad.
PubMed 20065793Van Stavern GP. Metabolic, hereditary, traumatic, and neoplastic optic neuropathies. Continuum (Minneap Minn). 2014 Aug;20(4 Neuro-ophthalmology):877-906. doi: 10.1212/01.CON.0000453313.37143.9b.
PubMed 25099099Costello F. Inflammatory optic neuropathies. Continuum (Minneap Minn). 2014 Aug;20(4 Neuro-ophthalmology):816-37. doi: 10.1212/01.CON.0000453316.60013.52.
PubMed 25099096Confino E, Mayden KL, Giglia RV, Vermesh M, Gleicher N. Pitfalls in sonographic imaging of the incompetent uterine cervix. Acta Obstet Gynecol Scand. 1986;65(6):593-7. doi: 10.3109/00016348609158394.
PubMed 3541483Rappoport D, Goldenberg-Cohen N, Luckman J, Leiba H. Parainfectious optic neuritis: manifestations in children vs adults. J Neuroophthalmol. 2014 Jun;34(2):122-9. doi: 10.1097/WNO.0000000000000113.
PubMed 24667772Boudreault K, Durand ML, Rizzo JF 3rd. Investigation-Directed Approach to Inflammatory Optic Neuropathies. Semin Ophthalmol. 2016;31(1-2):117-30. doi: 10.3109/08820538.2015.1114835.
PubMed 26959137Bennett JL. Finding NMO: The Evolving Diagnostic Criteria of Neuromyelitis Optica. J Neuroophthalmol. 2016 Sep;36(3):238-45. doi: 10.1097/WNO.0000000000000396.
PubMed 27529327Abouna GM. Extracorporeal liver perfusion using a new perfusion chamber. Lancet. 1968 Dec 7;2(7580):1216-8. doi: 10.1016/s0140-6736(68)91696-6. No abstract available.
PubMed 4177207Borvak J, Mayer V. UV-absorbance profile of human leukocytic ultrafiltrate after affinity chromatography on immobilized m-aminophenyl boronic acid: implication for transfer factor purification. Acta Virol. 1985 Mar;29(2):119-28.
PubMed 2860795Rhen T, Cidlowski JA. Antiinflammatory action of glucocorticoids--new mechanisms for old drugs. N Engl J Med. 2005 Oct 20;353(16):1711-23. doi: 10.1056/NEJMra050541. No abstract available.
PubMed 16236742Jabs DA, Rosenbaum JT, Foster CS, Holland GN, Jaffe GJ, Louie JS, Nussenblatt RB, Stiehm ER, Tessler H, Van Gelder RN, Whitcup SM, Yocum D. Guidelines for the use of immunosuppressive drugs in patients with ocular inflammatory disorders: recommendations of an expert panel. Am J Ophthalmol. 2000 Oct;130(4):492-513. doi: 10.1016/s0002-9394(00)00659-0.
PubMed 11024423Jermak CM, Dellacroce JT, Heffez J, Peyman GA. Triamcinolone acetonide in ocular therapeutics. Surv Ophthalmol. 2007 Sep-Oct;52(5):503-22. doi: 10.1016/j.survophthal.2007.06.004.
PubMed 17719372Arifulin AA, Burenkov MS, Davidenkov AV, Pichugin VIu, Salimov RM. [Mechanism of the effect of nonionizing radiation on animals at the level of sensory systems]. Radiobiologiia. 1986 Mar-Apr;26(2):247-50. Russian.
PubMed 3704120Rawson MD, Liversedge LA, Goldfarb G. Treatment of acute retrobulbar neuritis with corticotrophin. Lancet. 1966 Nov 12;2(7472):1044-6. doi: 10.1016/s0140-6736(66)92025-3. No abstract available.
PubMed 4162503
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrobulbar Methylprednisolone as Adjunctive Treatment in Optic Neuritis. Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT04942002
- Acronym / sponsor ID
- Neu-21-01
- Conditions
- Optic Neuritis, Treatment, Methylprednisolone
- Keywords
- Optic Neuritis, Methylprednisolone, Retrobulbar injection
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Asociación para Evitar la Ceguera en MéxicoUniversity, hospital or other
- Study start
- 15 Jun 2021 (estimated)
- Primary completion
- 15 Jun 2023 (estimated)
- Study completion
- 15 Sep 2023 (estimated)
- First posted
- 28 Jun 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.
A double-blind prospective randomized clinical trial of treatment for optic neuritis comparing visual outcome of patients treated by standard therapy (intravenous methylprednisolone) + placebo injection and standard therapy + retrobulbar methylprednisolone.
Detailed description
A double-blind prospective randomized clinical trial of treatment for optic neuritis comparing visual outcome of patients treated by standard therapy (intravenous methylprednisolone) + placebo injection and standard therapy + retrobulbar methylprednisolone.
Enrollment: 50. Randomized groups (2)
- Standard treatment + placebo
- Standard treatment + intervention Masking: Double (participant and outcomes assessor) Participants won't be aware to which group they were assigned. Investigator in charge of assessing outcomes and analyzing data won't be aware to which group participants were assigned
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized groups (2) 1. Standard treatment + placebo 2. Standard treatment + intervention
| Arm | Type | Receives |
|---|---|---|
| Standard treatment + placebo | Placebo comparator | Drug: Placebo Comparator: Standard treatment + placeboIntravenous Methylprednisolone succinate (1 g daily for 5 days) + paraocular injection of 0.9% saline solution |
| Standard treatment + intervention | Experimental | Drug: Methylprednisolone Acetate 40 MG/ML [Depo-Medrol]Intravenous Methylprednisolone succinate (1 g daily for 5 days) + retrobulbar injection of 2 cc (40 mg/mL) to methylprednisolone acetate |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Both genres
- Age between 18 and 85 years old.
- Optic neuritis diagnosis ( relative afferent pupillary defect, acquired dyschromatopsia, low vision, prechiasmatic campimetric defect)
- 1 month after symptoms started
- If is a bilateral simultaneous optic neuritis the eye with the worst vision will be included.
Key exclusion criteria (5 listed)
- Visual field better than 20/60 at the beginning of the study.
- History of optic neuritis in the eye under study.
- History of additional ophthalmological or neurological pathology that has caused visual loss in the eye under study.
- History of previous treatment with intravenous methylprednisolone since the onset of symptoms.
- History of high myopia.
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 |
|---|---|---|
| Methylprednisolone Acetate 40 MG/ML [Depo-Medrol]Also: Experimental: Standard treatment + interventionRetrobulbar injection performed by care provider | Drug | Standard treatment + intervention |
| Placebo Comparator: Standard treatment + placeboAlso: 1. Standard treatment + placeboIntravenous Methylprednisolone succinate (1 g daily for 5 days) + paraocular injection of 0.9% saline solution by care provider | Drug | Standard treatment + placebo |
Primary outcome
Change from Baseline Visual Capacity
Time frame: Initial visit, 2-week visit, 1-month visit, 3-month visit
Best corrected visual acuity
3 secondary outcomes
Change from Baseline Color vision
Time frame: Initial visit, 2-week visit, 1-month visit, 3-month visit
Change from Baseline Visual field defect
Time frame: Initial visit, 2-week visit, 1-month visit, 3-month visit
Change from Baseline Oct pRNFL (microns)
Time frame: 2-week visit, 3-month visit
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2021.
- Background: PubMed 27928326Yau GS, Lee JW, Lau PP, Tam VT, Wong WW, Yuen CY. Longitudinal Changes in Retinal Nerve Fibre Layer Thickness after an Isolated Unilateral Retrobulbar Optic Neuritis: 1-Year Results. Neuroophthalmology. 2015 Jan 22;39(1):22-25. doi: 10.3109/01658107.2014.984230. eCollection 2015 Feb.
- Background: PubMed 20065793Prasad S, Volpe NJ, Balcer LJ. Approach to optic neuropathies: clinical update. Neurologist. 2010 Jan;16(1):23-34. doi: 10.1097/NRL.0b013e3181be6fad.
- Background: PubMed 25099099Van Stavern GP. Metabolic, hereditary, traumatic, and neoplastic optic neuropathies. Continuum (Minneap Minn). 2014 Aug;20(4 Neuro-ophthalmology):877-906. doi: 10.1212/01.CON.0000453313.37143.9b.
- Background: PubMed 25099096Costello F. Inflammatory optic neuropathies. Continuum (Minneap Minn). 2014 Aug;20(4 Neuro-ophthalmology):816-37. doi: 10.1212/01.CON.0000453316.60013.52.
- Background: PubMed 3541483Confino E, Mayden KL, Giglia RV, Vermesh M, Gleicher N. Pitfalls in sonographic imaging of the incompetent uterine cervix. Acta Obstet Gynecol Scand. 1986;65(6):593-7. doi: 10.3109/00016348609158394.
- Background: PubMed 24667772Rappoport D, Goldenberg-Cohen N, Luckman J, Leiba H. Parainfectious optic neuritis: manifestations in children vs adults. J Neuroophthalmol. 2014 Jun;34(2):122-9. doi: 10.1097/WNO.0000000000000113.
- Background: PubMed 26959137Boudreault K, Durand ML, Rizzo JF 3rd. Investigation-Directed Approach to Inflammatory Optic Neuropathies. Semin Ophthalmol. 2016;31(1-2):117-30. doi: 10.3109/08820538.2015.1114835.
- Background: PubMed 27529327Bennett JL. Finding NMO: The Evolving Diagnostic Criteria of Neuromyelitis Optica. J Neuroophthalmol. 2016 Sep;36(3):238-45. doi: 10.1097/WNO.0000000000000396.
- Background: PubMed 4177207Abouna GM. Extracorporeal liver perfusion using a new perfusion chamber. Lancet. 1968 Dec 7;2(7580):1216-8. doi: 10.1016/s0140-6736(68)91696-6. No abstract available.
- Background: PubMed 2860795Borvak J, Mayer V. UV-absorbance profile of human leukocytic ultrafiltrate after affinity chromatography on immobilized m-aminophenyl boronic acid: implication for transfer factor purification. Acta Virol. 1985 Mar;29(2):119-28.
- Background: PubMed 16236742Rhen T, Cidlowski JA. Antiinflammatory action of glucocorticoids--new mechanisms for old drugs. N Engl J Med. 2005 Oct 20;353(16):1711-23. doi: 10.1056/NEJMra050541. No abstract available.
- Background: PubMed 11024423Jabs DA, Rosenbaum JT, Foster CS, Holland GN, Jaffe GJ, Louie JS, Nussenblatt RB, Stiehm ER, Tessler H, Van Gelder RN, Whitcup SM, Yocum D. Guidelines for the use of immunosuppressive drugs in patients with ocular inflammatory disorders: recommendations of an expert panel. Am J Ophthalmol. 2000 Oct;130(4):492-513. doi: 10.1016/s0002-9394(00)00659-0.
- Individual participant dataSharing planned: No. This study is confidential and no information will be shared with the participants.
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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.
Jorge Cárdenas-Belaunzarán, MD, MSc study director
Asociación Para Evitar la Ceguera en México I.A.P
Karen Flores-Guevara, MD principal investigator
Asociación Para Evitar la Ceguera en México I.A.P
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Methylprednisolone Acetate 40 MG/ML [Depo-Medrol] in people with Optic Neuritis and Treatment, run by Asociación para Evitar la Ceguera en México at 1 site in Mexico.
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 6 inclusion and 5 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 28 Jun 2021. 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 Mexico. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Jorge Cárdenas-Belaunzarán, MD, MSc (5510841400 ext. 1207, jorge.cardenas@apec.com.mx), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline Visual Capacity (time frame: Initial visit, 2-week visit, 1-month visit, 3-month visit). 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 NCT04942002, which also lists 24 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 28 Jun 2021.