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

Diabetic Macular Edema Clinical Trial

— 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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02314299
• Other study ID #: SPIOC-101
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: December 2, 2014
• Last updated: October 2, 2015
• Start date: November 2014
• Est. completion date: June 2015

Study information

• Verified date: October 2015
• Source: Stealth BioTherapeutics Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: June 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Age-related Macular Degeneration
• Diabetic Macular Edema
• Edema
• Macular Degeneration
• Macular Edema

Intervention

Drug:
• MTP-131

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Stealth BioTherapeutics Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence and severity of systemic and ocular adverse events		From Baseline to Day 28	Yes
Primary	Change from Baseline in vital sign measurements		From Baseline to Day 28	Yes
Primary	Change from Baseline in best corrected visual acuity (BCVA) as measured with the early treatment diabetic retinopathy study (ETDRS) scale		From Baseline to Day 28	Yes
Primary	Change from Baseline in slit lamp examinations		From Baseline to Day 28	Yes
Primary	Change from Baseline in intraocular pressure		From Baseline to Day 28	Yes
Primary	Change from Baseline in dilated fundoscopic examinations		From Baseline to Day 28	Yes
Primary	Change from Baseline in central subfield thickness		From Baseline to Day 28	Yes
Secondary	Change in central subfield thickness	Diabetic Macular Edema (DME) subjects only	From Baseline to Day 28	No
Secondary	Change from Baseline in widefield angiography	Diabetic Macular Edema (DME) subjects only	From Baseline to Day 28	No
Secondary	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	From Baseline to Day 28	No
Secondary	Change from Baseline in best corrected visual acuity (BCVA) as measured with the early treatment diabetic retinopathy study (ETDRS) scale	All subjects	From baseline to Day 28	No