Vitreomacular TractionPhase 2TOTEMNCT04300881
Treatment of Post-Ocriplasmin Therapy Vitreolysis Induced Subretinal Fluid With Eplerenone (Mineralocorticoid Antagonists)
A Phase 2 study testing Eplerenone in people with Vitreomacular Traction and Subretinal Edema, run by Wagner Macula & Retina Center at 1 site in United States.
Trial summary
Evaluate the efficacy of eplerenone as an adjunctive treatment to intravitreal ocriplasmin for subretinal fluid in comparison to a control group of only receiving intravitreal ocriplasmin in patients with symptomatic vitreomacular adhesion. Read more about this study
- Who is it for?
- Ages 19 years and olderHealthy volunteers can take part
- Conditions the study is for
- Vitreomacular Traction, Subretinal Edema
- What is being tested?
- Eplerenone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Oct 2019to 5 Jan 2021
- Phase
- Phase 2
- 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 19 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age > 18 years of age
- Symptomatic VMA, VMT, or macular hole
- BCVA 20/30 - CF 3' Snellen equivalent
- Willing and able to provide signed informed consent and willing to undertake all scheduled study-related assessments, visits, and treatments
- JETREA® treatment naïve
Who cannot join
- Patients who are pregnant, planning to become pregnant, or breastfeeding a child
- Uncontrolled ocular hypertension or glaucoma in study (defined as IOP ≥ 25mm Hg or a cup to disc ratio (CDR) > 0.8 despite treatment with anti-glaucoma medication)
- Active malignancies within the last 12 months except appropriately treated carcinoma in situ of the crevices, melanoma, and prostate cancers treated with a curative intent
- Inability to comply with study or follow-up procedures
- Women who may become pregnant or lactating or intend to become pregnant during the study
- Known drug allergy to ocriplasmin or eplerenone
- Patients with known contraindications Eplerenone as outlined in the package insert
Trial locations and contacts
1 site in 1 country.
United States1 site
Wagner Macula & Retina Center
Norfolk, Virginia, 23502
About this study
Official title: Treatment of Post-Ocriplasmin Therapy Vitreolysis Induced Subretinal Fluid With Eplerenone (Mineralocorticoid Antagonists): The TOTEM Study
Evaluate the efficacy of eplerenone as an adjunctive treatment to intravitreal ocriplasmin for subretinal fluid in comparison to a control group of only receiving intravitreal ocriplasmin in patients with symptomatic vitreomacular adhesion.
- Conditions
- Vitreomacular Traction, Subretinal Edema
- Being tested
- Eplerenone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EplerenoneDrug
Following intravitreal ocriplasmin therapy
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Eplerenone Receives: Drug: Eplerenone |
| Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes from baseline in Central Foveal Thickness (CFT) over time
Changes as assessed via SD-OCT from the lowest CST measurement in the study, due to disease activity
Measured: through study completion, an average of 1 year
Secondary outcomes (1)
Changes from baseline in Best Corrected Visual Acuity (BCVA) over time
Changes as assessed using the visual acuity chart at a starting distance of 4 meters
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2020
- Study start4 Oct 2019
- Primary completion5 Jan 2021
- Study completion5 Jan 2021
Why it stopped: Enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vitreomacular TractionStudies 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wagner Macula & Retina Center
- Sponsor type
- University, hospital or other
- Collaborators
- ThromboGenics
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04300881
- Sponsor's protocol ID
- WM562718
- Acronym
- TOTEM
- Status last verified
- Jan 2021
- First submitted
- 21 Nov 2019
- Last updated
- 8 Jan 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Post-Ocriplasmin Therapy Vitreolysis Induced Subretinal Fluid With Eplerenone (Mineralocorticoid Antagonists): The TOTEM Study
- ClinicalTrials.gov ID
- NCT04300881
- Acronym / sponsor ID
- TOTEM / WM562718
- Conditions
- Vitreomacular Traction, Subretinal Edema
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Enrollment
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Wagner Macula & Retina CenterUniversity, hospital or other
- Collaborators
- ThromboGenics
- Study start
- 4 Oct 2019 (actual)
- Primary completion
- 5 Jan 2021 (actual)
- Study completion
- 5 Jan 2021 (actual)
- First posted
- 9 Mar 2020 (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.
Evaluate the efficacy of eplerenone as an adjunctive treatment to intravitreal ocriplasmin for subretinal fluid in comparison to a control group of only receiving intravitreal ocriplasmin in patients with symptomatic vitreomacular adhesion.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Drug: EplerenoneEplerenone |
| Control | No intervention | – |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age > 18 years of age
- Symptomatic VMA, VMT, or macular hole
- BCVA 20/30 - CF 3' Snellen equivalent
- Willing and able to provide signed informed consent and willing to undertake all scheduled study-related assessments, visits, and treatments
- JETREA® treatment naïve
Key exclusion criteria (7 listed)
- Patients who are pregnant, planning to become pregnant, or breastfeeding a child
- Uncontrolled ocular hypertension or glaucoma in study (defined as IOP ≥ 25mm Hg or a cup to disc ratio (CDR) > 0.8 despite treatment with anti-glaucoma medication)
- Active malignancies within the last 12 months except appropriately treated carcinoma in situ of the crevices, melanoma, and prostate cancers treated with a curative intent
- Inability to comply with study or follow-up procedures
- Women who may become pregnant or lactating or intend to become pregnant during the study
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 |
|---|---|---|
| EplerenoneFollowing intravitreal ocriplasmin therapy | Drug | Treatment |
Primary outcome
Changes from baseline in Central Foveal Thickness (CFT) over time
Time frame: through study completion, an average of 1 year
Changes as assessed via SD-OCT from the lowest CST measurement in the study, due to disease activity
1 secondary outcome
Changes from baseline in Best Corrected Visual Acuity (BCVA) over time
Time frame: through study completion, an average of 1 year
Results and safety
The study was stopped early (reason given: Enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2021.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Eplerenone in people with Vitreomacular Traction and Subretinal Edema, run by Wagner Macula & Retina Center at 1 site in United States.
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 5 inclusion and 7 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: stopped early, as of the sponsor's last update on 8 Jan 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 United States. 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.
What does this 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Enrollment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes from baseline in Central Foveal Thickness (CFT) over time (time frame: through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Jan 2021.