Clinical trial NCT02314299: A Study of MTP-131 Topical Ophthalmic Solution in Subjects With Diabetic Macular Edema and Non-Exudative Intermediate Age-related Macular Degeneration
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
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Diabetic Macular Edema
Age-related Macular Degeneration
Keywords: Macular edema
Macular degeneration
MTP-131
Ocuvia™
Lead sponsor: Stealth BioTherapeutics Inc.
Sponsor class: INDUSTRY
First posted: 2014-12-11
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Incidence and severity of systemic and ocular adverse events
timeFrame: From Baseline to Day 28
measure: Change from Baseline in vital sign measurements
timeFrame: From Baseline to Day 28
measure: Change from Baseline in best corrected visual acuity (BCVA) as measured with the early treatment diabetic retinopathy study (ETDRS) scale
timeFrame: From Baseline to Day 28
measure: Change from Baseline in slit lamp examinations
timeFrame: From Baseline to Day 28
measure: Change from Baseline in intraocular pressure
timeFrame: From Baseline to Day 28
measure: Change from Baseline in dilated fundoscopic examinations
timeFrame: From Baseline to Day 28
measure: Change from Baseline in central subfield thickness
timeFrame: From Baseline to Day 28
Secondary outcomes:
measure: Change in central subfield thickness
timeFrame: From Baseline to Day 28
measure: Change from Baseline in widefield angiography
timeFrame: From Baseline to Day 28
measure: Change from Baseline in fundus autofluorescence pattern including the occurrence of and aggregate size of areas of macular atrophy
timeFrame: From Baseline to Day 28
measure: Change from Baseline in best corrected visual acuity (BCVA) as measured with the early treatment diabetic retinopathy study (ETDRS) scale
timeFrame: From baseline to Day 28
Other outcomes:
Locations:
city: Boston
country: United States
state: Massachusetts
Study officials:
References: