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A Study of MTP-131 Topical Ophthalmic Solution in Subjects With Diabetic Macular Edema and Non-Exudative Intermediate Age-related Macular Degeneration (SPIOC-101)

Primary Purpose

Diabetic Macular Edema, Age-related Macular Degeneration

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
MTP-131
Sponsored by
Stealth BioTherapeutics Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetic Macular Edema focused on measuring Macular edema, Macular degeneration, MTP-131, Ocuvia™

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • General:

    1. Adults aged ≥18 and ≤ 80 years
    2. 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:

    1. Central subfield thickness (CST) ≥325 microns as measured by spectral domain optical coherence tomography (SD-OCT) at Screening and Baseline Visits
    2. BCVA (ETDRS) no better than 20/25 in the study eye
    3. BCVA (ETDRS) no worse than 20/640 in either eye

  • AMD Treatment Group:

    1. 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)
    2. BCVA (ETDRS) no worse than 20/400 in either eye

Exclusion Criteria:

  • General:

    1. Inability to self-administer eye drops
    2. 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)
    3. 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
    4. Have a glycosylated hemoglobin (HbA1c) ≥ 12%

  • Ocular Conditions:

    1. 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

    2. 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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Low Dose Regimen

High Dose Regimen

Arm Description

MTP-131 (Low Dose) sterile topical ophthalmic solution twice a day into the study eye

MTP-131 (High Dose) sterile topical ophthalmic solution twice a day into the study eye

Outcomes

Primary Outcome Measures

Incidence and severity of systemic and ocular adverse events
Change from Baseline in vital sign measurements
Change from Baseline in best corrected visual acuity (BCVA) as measured with the early treatment diabetic retinopathy study (ETDRS) scale
Change from Baseline in slit lamp examinations
Change from Baseline in intraocular pressure
Change from Baseline in dilated fundoscopic examinations
Change from Baseline in central subfield thickness

Secondary Outcome Measures

Change in central subfield thickness
Diabetic Macular Edema (DME) subjects only
Change from Baseline in widefield angiography
Diabetic Macular Edema (DME) subjects only
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
Change from Baseline in best corrected visual acuity (BCVA) as measured with the early treatment diabetic retinopathy study (ETDRS) scale
All subjects

Full Information

First Posted
December 2, 2014
Last Updated
October 2, 2015
Sponsor
Stealth BioTherapeutics Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02314299
Brief Title
A Study of MTP-131 Topical Ophthalmic Solution in Subjects With Diabetic Macular Edema and Non-Exudative Intermediate Age-related Macular Degeneration
Acronym
SPIOC-101
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.
Study Type
Interventional

2. Study Status

Record Verification Date
October 2015
Overall Recruitment Status
Completed
Study Start Date
November 2014 (undefined)
Primary Completion Date
May 2015 (Actual)
Study Completion Date
June 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Stealth BioTherapeutics Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Macular Edema, Age-related Macular Degeneration
Keywords
Macular edema, Macular degeneration, MTP-131, Ocuvia™

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Low Dose Regimen
Arm Type
Experimental
Arm Description
MTP-131 (Low Dose) sterile topical ophthalmic solution twice a day into the study eye
Arm Title
High Dose Regimen
Arm Type
Experimental
Arm Description
MTP-131 (High Dose) sterile topical ophthalmic solution twice a day into the study eye
Intervention Type
Drug
Intervention Name(s)
MTP-131
Primary Outcome Measure Information:
Title
Incidence and severity of systemic and ocular adverse events
Time Frame
From Baseline to Day 28
Title
Change from Baseline in vital sign measurements
Time Frame
From Baseline to Day 28
Title
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
Title
Change from Baseline in slit lamp examinations
Time Frame
From Baseline to Day 28
Title
Change from Baseline in intraocular pressure
Time Frame
From Baseline to Day 28
Title
Change from Baseline in dilated fundoscopic examinations
Time Frame
From Baseline to Day 28
Title
Change from Baseline in central subfield thickness
Time Frame
From Baseline to Day 28
Secondary Outcome Measure Information:
Title
Change in central subfield thickness
Description
Diabetic Macular Edema (DME) subjects only
Time Frame
From Baseline to Day 28
Title
Change from Baseline in widefield angiography
Description
Diabetic Macular Edema (DME) subjects only
Time Frame
From Baseline to Day 28
Title
Change from Baseline in fundus autofluorescence pattern including the occurrence of and aggregate size of areas of macular atrophy
Description
Age-Related Macular Degeneration (AMD) subjects only
Time Frame
From Baseline to Day 28
Title
Change from Baseline in best corrected visual acuity (BCVA) as measured with the early treatment diabetic retinopathy study (ETDRS) scale
Description
All subjects
Time Frame
From baseline to Day 28

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 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 Exclusion Criteria: 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: 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
Facility Information:
City
Boston
State/Province
Massachusetts
Country
United States

12. IPD Sharing Statement

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A Study of MTP-131 Topical Ophthalmic Solution in Subjects With Diabetic Macular Edema and Non-Exudative Intermediate Age-related Macular Degeneration

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