Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02314299
Recruitment Status : Completed
First Posted : December 11, 2014
Last Update Posted : October 26, 2015
Sponsor:
Information provided by (Responsible Party):
Stealth BioTherapeutics Inc.

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.

Condition or disease Intervention/treatment Phase
Diabetic Macular Edema Age-related Macular Degeneration Drug: MTP-131 Phase 1 Phase 2

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Non-Randomized
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : November 2014
Actual Primary Completion Date : May 2015
Actual Study Completion Date : June 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Low Dose Regimen
MTP-131 (Low Dose) sterile topical ophthalmic solution twice a day into the study eye
Drug: MTP-131
Experimental: High Dose Regimen
MTP-131 (High Dose) sterile topical ophthalmic solution twice a day into the study eye
Drug: MTP-131



Primary Outcome Measures :
  1. Incidence and severity of systemic and ocular adverse events [ Time Frame: From Baseline to Day 28 ]
  2. Change from Baseline in vital sign measurements [ Time Frame: From Baseline to Day 28 ]
  3. 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 ]
  4. Change from Baseline in slit lamp examinations [ Time Frame: From Baseline to Day 28 ]
  5. Change from Baseline in intraocular pressure [ Time Frame: From Baseline to Day 28 ]
  6. Change from Baseline in dilated fundoscopic examinations [ Time Frame: From Baseline to Day 28 ]
  7. Change from Baseline in central subfield thickness [ Time Frame: From Baseline to Day 28 ]

Secondary Outcome Measures :
  1. Change in central subfield thickness [ Time Frame: From Baseline to Day 28 ]
    Diabetic Macular Edema (DME) subjects only

  2. Change from Baseline in widefield angiography [ Time Frame: From Baseline to Day 28 ]
    Diabetic Macular Edema (DME) subjects only

  3. 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 ]
    Age-Related Macular Degeneration (AMD) subjects only

  4. 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 ]
    All subjects



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02314299


Locations
Layout table for location information
United States, Massachusetts
Boston, Massachusetts, United States
Sponsors and Collaborators
Stealth BioTherapeutics Inc.

Layout table for additonal information
Responsible Party: Stealth BioTherapeutics Inc.
ClinicalTrials.gov Identifier: NCT02314299     History of Changes
Other Study ID Numbers: SPIOC-101
First Posted: December 11, 2014    Key Record Dates
Last Update Posted: October 26, 2015
Last Verified: October 2015

Keywords provided by Stealth BioTherapeutics Inc.:
Macular edema
Macular degeneration
MTP-131
Ocuvia™

Additional relevant MeSH terms:
Layout table for MeSH terms
Edema
Macular Degeneration
Macular Edema
Signs and Symptoms
Retinal Degeneration
Retinal Diseases
Eye Diseases
Pharmaceutical Solutions
Ophthalmic Solutions