Phase 2
Completed N=32
A Three Part Study of MGV354 in Ocular Hypertension or Glaucoma
Source: ClinicalTrials.gov NCT02743780 ↗Enrolled (actual)
32
Serious AEs
0.0%
Results posted
Aug 2017
Primary outcomePrimary: Part 3: Change in Diurnal IOP (Averaged Over 8 AM, 10 AM, Noon, 4 PM, and 8 PM) From Baseline to Day 8 — -0.6; -1.1 mmHg
Summary
The purpose of this study is to determine if the clinical profile of topical-ocular MGV354 merits further development for the indication of lowering intraocular pressure (IOP).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Part 3: Change in Diurnal IOP (Averaged Over 8 AM, 10 AM, Noon, 4 PM, and 8 PM) From Baseline to Day 8 |
-0.6; -1.1 | — |
| PRIMARY Part 3: Change in IOP From Baseline to Day 8 at 8 AM, 10 AM, Noon, 4 PM, and 8 PM |
0.1; -1.5; -0.4; -1.5; -0.2; -0.2 | — |
| SECONDARY Part 3: Change From Baseline in IOP at 36 Hours and 48 Hours Post Day 7 Administration |
-1.58; -1.09; -1.39; -0.12 | — |
| SECONDARY Part 1: Maximum Observed Concentration [Cmax (ng/mL)] |
0.073; 0.098; 0.327 | — |
| SECONDARY Part 1: Time to Reach Maximum Concentration [Tmax (h)] |
0.483; 0.559; 0.575 | — |
| SECONDARY Part 1: Area Under the Plasma Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration [AUClast (ng*h/mL)] |
0.213; 0.157; 1.611 | — |
| SECONDARY Part 1: Area Under the Plasma Concentration-time Curve From Time Zero to 120 Hours Post Dose [AUC0-120 (ng*h/mL)] |
— | — |
| SECONDARY Part 1: Area Under the Concentration-time Curve From 0 to Infinity [AUCinf (ng*h/mL)] |
— | — |
| SECONDARY Part 1: Terminal Elimination Half-life [t1/2 (h)] |
— | — |
| SECONDARY Part 2: Maximum Observed Concentration [Cmax (ng/mL)] |
0.077; 0.139; 0.132; 0.188 | — |
| SECONDARY Part 2: Time to Reach Maximum Concentration [Tmax (h)] |
0.533; 0.567; 0.550; 0.533 | — |
| SECONDARY Part 2: Area Under the Concentration-time Curve From 0 to the End of the Dosing Interval Tau [AUCtau (ng*h/mL)] |
0.723; 0.392; 1.461 | — |
| SECONDARY Part 2: Accumulation Ratio (Racc) |
1.893; 1.391 | — |
| SECONDARY Part 3: Observed Concentration at 12 Hours Following Drug Administration [C12 (ng/mL)] |
0.0881; 0.1488 | — |
Eligibility Criteria
Inclusion Criteria
- Documented informed consent.
- Part 1: 18 to 70 years of age;
- Parts 2 and 3: 18 years of age or older;
- Able to communicate well with the investigator and understand and comply with the requirements of the study;
- Body Mass Index (BMI) between 18 and 39;
- In case of contact lens wear, willing to remove lenses 30 minutes before the first assessment until the end of the study. Corrective spectacles may be worn as needed.
- Sitting vital signs (systolic and diastolic blood pressure and pulse rate) within normal ranges as specified in the protocol;
- Part 1 (Healthy Volunteers): In good health as determined by past medical history, physical examination, vital signs, electrocardiogram, and laboratory tests at screening.
- Parts 2 and 3 (Patients): Diagnosed with open-angle glaucoma or confirmed ocular hypertension; mean IOP measurements in at least one eye after washout as specified in the protocol
- Other protocol-specified inclusion criteria may apply.
Exclusion criteria
- History of hypersensitivity to any of the study drugs or to drugs of similar chemical classes;
- History of or current presence of clinically significant ECG abnormalities or arrhythmias;
- History of malignancy of any organ system (other than localized basal cell carcinoma of the skin or in-situ cervical or breast cancer), treated or untreated, within the past 5 years;
- Known clinical history of heart failure, myocardial infarction, or stroke;
- Exposure during the four weeks preceding the Screening visit to any topical, inhaled, or systemic corticosteroids;
- Angle grade less than Grade 2 in either eye;
- Any abnormality, including corneal thickness > 620 microns, preventing reliable applanation tonometry;
- Pregnant or lactating women and women of child-bearing potential;
- Sexually active males must agree to use a condom during intercourse while taking drug and for 6 days after stopping MGV354 medication and should not father a child in this period;
- Positive HIV, Hepatitis B Ag or Hepatitis C Ab test result at Screening;
- Abnormal liver function tests;
- History or presence of impaired renal function;
- Part 1 (Healthy Volunteers): Use of any NEW prescription drugs or herbal supplements within four (4) weeks prior to initial dosing, and/or NEW over-the-counter (OTC) medication, dietary supplements (vitamins included) within two (2) weeks prior to initial dosing.
- Parts 2 and 3 (Patients): Patients with related disease condition(s) including any form of glaucoma other than open-angle glaucoma and pseudoexfoliation and/or pigment dispersion components; patients who cannot safely discontinue use of all topical ocular and/or systemic IOP-lowering medication according to protocol-specified Washout Schedule; patients with ocular diseases or conditions as specified in the protocol; patients taking certain medications as specified in the protocol;
- Other protocol-specified exclusion criteria may apply.
Data sourced from ClinicalTrials.gov (NCT02743780). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.