Diabetic Macular EdemaPhase 1/2SPIOC-101NCT02314299
A Study of MTP-131 Topical Ophthalmic Solution in Subjects With Diabetic Macular Edema and Non-Exudative Intermediate Age-related Macular Degeneration
A Phase 1/2 study testing MTP-131 in people with Diabetic Macular Edema and Age-related Macular Degeneration, run by Stealth BioTherapeutics Inc. at 1 site in United States.
Trial summary
This is a Phase 1/2, open-label, dose-escalation clinical study, enrolling 21 subjects in one of the two treatment groups to determine the effects of topical ocular administration of low dose or high dose MTP-131 given twice a day in subjects with Diabetic Macular Edema and Age-Related Macular Degeneration. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Diabetic Macular Edema, Age-related Macular Degeneration
- What is being tested?
- MTP-131
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2014to Jun 2015
- Phase
- Phase 1/2
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- General:
- Adults aged ≥18 and ≤ 80 years
- Women of childbearing potential must have a negative urine pregnancy test at Baseline and agree to use a highly effective method of contraception throughout the study and 60 days after the last dose of study drug.
- DME Treatment Group:
- Central subfield thickness (CST) ≥325 microns as measured by spectral domain optical coherence tomography (SD-OCT) at Screening and Baseline Visits
- BCVA (ETDRS) no better than 20/25 in the study eye
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- BCVA (ETDRS) no worse than 20/640 in either eye
- AMD Treatment Group:
- Non-exudative, intermediate age-related macular degeneration defined as an eye(s) having extensive intermediate drusen (10 or more drusen 63μm - 124μm) or large drusen (1 or more ≥125 μm) with no evidence of advanced AMD (i.e., no choroidal neovascularization or macular atrophy)
- BCVA (ETDRS) no worse than 20/400 in either eye
Who cannot join
- General:
- Inability to self-administer eye drops
- Current use of or likely need for systemic medications known to be toxic to the lens, retina or optic nerve (for example deferoxamine, chloroquine/hydroxychloroquine [Plaquenil], tamoxifen, phenothiazines and ethambutol)
- Any medical condition that, in the opinion of the investigator, would preclude safe participation in the study or completion of all study requirements and examinations
- Have a glycosylated hemoglobin (HbA1c) ≥ 12%
- Ocular Conditions:
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- Any ocular condition in the study eye that in the opinion of the investigator would prevent improvement in visual acuity or successful completion of any study examination
- Ocular hypertension or glaucoma, dry eye, and any other ocular pathology in the study eye requiring treatment with topical ophthalmic drops
- Other protocol-defined inclusion/exclusion criteria may apply
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1/2, Open-Label, Dose-Escalation, Single Center, Clinical Study of MTP-131 (Ocuvia™) Topical Ophthalmic Solution in Subjects With Diabetic Macular Edema and Non-Exudative Intermediate Age-related Macular Degeneration.
This is a Phase 1/2, open-label, dose-escalation clinical study, enrolling 21 subjects in one of the two treatment groups to determine the effects of topical ocular administration of low dose or high dose MTP-131 given twice a day in subjects with Diabetic Macular Edema and Age-Related Macular Degeneration.
- Being tested
- MTP-131
- Keywords
- Macular edema, Macular degeneration, MTP-131, Ocuvia™
- Medical subject headings
- Macular Degeneration, Macular Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MTP-131Drug
| Study group | Role | What they receive |
|---|---|---|
| Low Dose Regimen | Experimental | MTP-131 (Low Dose) sterile topical ophthalmic solution twice a day into the study eye Receives: Drug: MTP-131 |
| High Dose Regimen | Experimental | MTP-131 (High Dose) sterile topical ophthalmic solution twice a day into the study eye Receives: Drug: MTP-131 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and severity of systemic and ocular adverse events
Measured: From Baseline to Day 28
Change from Baseline in vital sign measurements
Measured: From Baseline to Day 28
Change from Baseline in best corrected visual acuity (BCVA) as measured with the early treatment diabetic retinopathy study (ETDRS) scale
Measured: From Baseline to Day 28
Change from Baseline in slit lamp examinations
Measured: From Baseline to Day 28
Change from Baseline in intraocular pressure
Measured: From Baseline to Day 28
Change from Baseline in dilated fundoscopic examinations
Measured: From Baseline to Day 28
Change from Baseline in central subfield thickness
Measured: From Baseline to Day 28
Secondary outcomes (4)
Change in central subfield thickness
Diabetic Macular Edema (DME) subjects only
Measured: From Baseline to Day 28
Change from Baseline in widefield angiography
Diabetic Macular Edema (DME) subjects only
Measured: From Baseline to Day 28
Change from Baseline in fundus autofluorescence pattern including the occurrence of and aggregate size of areas of macular atrophy
Age-Related Macular Degeneration (AMD) subjects only
Measured: From Baseline to Day 28
Change from Baseline in best corrected visual acuity (BCVA) as measured with the early treatment diabetic retinopathy study (ETDRS) scale
All subjects
Measured: From baseline to Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2014 (estimated)
- Study startNov 2014
- Primary completionMay 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stealth BioTherapeutics Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02314299
- Sponsor's protocol ID
- SPIOC-101
- Acronym
- SPIOC-101
- Status last verified
- Oct 2015
- First submitted
- 2 Dec 2014
- Last updated
- 26 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1/2, Open-Label, Dose-Escalation, Single Center, Clinical Study of MTP-131 (Ocuvia™) Topical Ophthalmic Solution in Subjects With Diabetic Macular Edema and Non-Exudative Intermediate Age-related Macular Degeneration.
- ClinicalTrials.gov ID
- NCT02314299
- Acronym / sponsor ID
- SPIOC-101 / SPIOC-101
- Keywords
- Macular edema, Macular degeneration, MTP-131, Ocuvia™
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Stealth BioTherapeutics Inc.Industry (pharma, biotech, devices)
- Study start
- Nov 2014
- Primary completion
- May 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 11 Dec 2014 (estimated)
- 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.
This is a Phase 1/2, open-label, dose-escalation clinical study, enrolling 21 subjects in one of the two treatment groups to determine the effects of topical ocular administration of low dose or high dose MTP-131 given twice a day in subjects with Diabetic Macular Edema and Age-Related Macular Degeneration.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low Dose Regimen | Experimental | Drug: MTP-131MTP-131 (Low Dose) sterile topical ophthalmic solution twice a day into the study eye |
| High Dose Regimen | Experimental | Drug: MTP-131MTP-131 (High Dose) sterile topical ophthalmic solution twice a day into the study eye |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- General:
- DME Treatment Group:
- AMD Treatment Group:
Key exclusion criteria (9 listed)
- General:
- Ocular Conditions:
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 |
|---|---|---|
| MTP-131 | Drug | High Dose Regimen, Low Dose Regimen |
Primary outcome
Incidence and severity of systemic and ocular adverse events
Time frame: From Baseline to Day 28
Change from Baseline in vital sign measurements
Time frame: From Baseline to Day 28
Change from Baseline in best corrected visual acuity (BCVA) as measured with the early treatment diabetic retinopathy study (ETDRS) scale
Time frame: From Baseline to Day 28
Change from Baseline in slit lamp examinations
Time frame: From Baseline to Day 28
Change from Baseline in intraocular pressure
Time frame: From Baseline to Day 28
Change from Baseline in dilated fundoscopic examinations
Time frame: From Baseline to Day 28
Change from Baseline in central subfield thickness
Time frame: From Baseline to Day 28
4 secondary outcomes
Change in central subfield thickness
Time frame: From Baseline to Day 28
Change from Baseline in widefield angiography
Time frame: From Baseline to Day 28
Change from Baseline in fundus autofluorescence pattern including the occurrence of and aggregate size of areas of macular atrophy
Time frame: From Baseline to Day 28
Change from Baseline in best corrected visual acuity (BCVA) as measured with the early treatment diabetic retinopathy study (ETDRS) scale
Time frame: From baseline to Day 28
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2015.
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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 1/2 study testing MTP-131 in people with Diabetic Macular Edema and Age-related Macular Degeneration, run by Stealth BioTherapeutics Inc. 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 10 inclusion and 9 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: finished, as of the sponsor's last update on 26 Oct 2015. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Incidence and severity of systemic and ocular adverse events (time frame: From Baseline to Day 28). The study lists 7 primary outcomes in all. 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 26 Oct 2015.