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

NCT02314299 | Completed Phase 1

• 1 other identifier: SPIOC-101
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetic Macular Edema; Age-related Macular Degeneration

Keywords

Macular edema; Macular degeneration; MTP-131; Ocuvia™

Outcome Measures

Primary Outcomes (7)

• Incidence and severity of systemic and ocular adverse events

  From Baseline to Day 28

• Change from Baseline in vital sign measurements

  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

  From Baseline to Day 28

• Change from Baseline in slit lamp examinations

  From Baseline to Day 28

• Change from Baseline in intraocular pressure

  From Baseline to Day 28

• Change from Baseline in dilated fundoscopic examinations

  From Baseline to Day 28

• Change from Baseline in central subfield thickness

  From Baseline to Day 28

Secondary Outcomes (4)

• Change in central subfield thickness

  From Baseline to Day 28

• Change from Baseline in widefield angiography

  From Baseline to Day 28

• Change from Baseline in fundus autofluorescence pattern including the occurrence of and aggregate size of areas of macular atrophy

  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

  From baseline to Day 28

Study Arms (2)

Low Dose Regimen

EXPERIMENTAL

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

Drug: MTP-131

High Dose Regimen

EXPERIMENTAL

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

Drug: MTP-131

Interventions

MTP-131 DRUG

High Dose Regimen; Low Dose Regimen

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Stealth BioTherapeutics Inc.: lead

Study Sites (1)

Unknown Facility

Boston, Massachusetts, United States

Location

MeSH Terms

Conditions

Macular Degeneration; Macular Edema

Interventions

arginyl-2,'6'-dimethyltyrosyl-lysyl-phenylalaninamide

Condition Hierarchy (Ancestors)

Retinal Degeneration; Retinal Diseases; Eye Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 2, 2014
• First Posted: December 11, 2014
• Study Start: November 1, 2014
• Primary Completion: May 1, 2015
• Study Completion: June 1, 2015
• Last Updated: October 26, 2015

Record last verified: 2015-10

Locations

US (1)