Trial Outcomes & Findings for Study of MP0112 Intravitreal Injection in Patients With Diabetic Macular Edema (NCT NCT01042678)
NCT ID: NCT01042678
Last Updated: 2014-05-13
Results Overview
Safety and tolerability was assessed by vital signs, clinical laboratory evaluations, ophthalmological examinations, intraocular pressure, the presence of anti-drug antibodies and the collection of adverse events. An adverse event was considered any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug. Preexisting conditions that worsened during the study were reported as adverse events.
TERMINATED
PHASE1
18 participants
16 weeks
2014-05-13
Participant Flow
Participant milestones
| Measure |
MP0112 (0.04 mg)
Single 0.04 mg intravitreal injection of MP0112 in the study eye.
|
MP0112 (0.15 mg)
Single 0.15 mg intravitreal injection of MP0112 in the study eye.
|
MP0112 (0.4 mg)
Single 0.4 mg intravitreal injection of MP0112 in the study eye.
|
MP0112 (1.0 mg)
Single 1.0 mg intravitreal injection of MP0112 in the study eye.
|
MP0112 (2.0 mg)
Single 2.0 mg intravitreal injection of MP0112 in the study eye.
|
MP0112 (3.6 mg)
Single 3.6 mg intravitreal injection of MP0112 in the study eye.
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
6
|
6
|
6
|
0
|
0
|
0
|
|
Overall Study
COMPLETED
|
5
|
6
|
6
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
MP0112 (0.04 mg)
Single 0.04 mg intravitreal injection of MP0112 in the study eye.
|
MP0112 (0.15 mg)
Single 0.15 mg intravitreal injection of MP0112 in the study eye.
|
MP0112 (0.4 mg)
Single 0.4 mg intravitreal injection of MP0112 in the study eye.
|
MP0112 (1.0 mg)
Single 1.0 mg intravitreal injection of MP0112 in the study eye.
|
MP0112 (2.0 mg)
Single 2.0 mg intravitreal injection of MP0112 in the study eye.
|
MP0112 (3.6 mg)
Single 3.6 mg intravitreal injection of MP0112 in the study eye.
|
|---|---|---|---|---|---|---|
|
Overall Study
Physician Decision
|
1
|
0
|
0
|
0
|
0
|
0
|
Baseline Characteristics
Study of MP0112 Intravitreal Injection in Patients With Diabetic Macular Edema
Baseline characteristics by cohort
| Measure |
MP0112 (0.04 mg)
n=6 Participants
Single 0.04 mg intravitreal injection of MP0112 in the study eye.
|
MP0112 (0.15 mg)
n=6 Participants
Single 0.15 mg intravitreal injection of MP0112 in the study eye.
|
MP0112 (0.4 mg)
n=6 Participants
Single 0.4 mg intravitreal injection of MP0112 in the study eye.
|
Total
n=18 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
62.7 Years
STANDARD_DEVIATION 8.4 • n=5 Participants
|
67.5 Years
STANDARD_DEVIATION 9.9 • n=7 Participants
|
64.2 Years
STANDARD_DEVIATION 10.3 • n=5 Participants
|
64.8 Years
STANDARD_DEVIATION 9.2 • n=4 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 16 weeksPopulation: All treated participants.
Safety and tolerability was assessed by vital signs, clinical laboratory evaluations, ophthalmological examinations, intraocular pressure, the presence of anti-drug antibodies and the collection of adverse events. An adverse event was considered any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug. Preexisting conditions that worsened during the study were reported as adverse events.
Outcome measures
| Measure |
MP0112 (0.04 mg)
n=6 Participants
Single 0.04 mg intravitreal injection of MP0112 in the study eye.
|
MP0112 (0.15 mg)
n=6 Participants
Single 0.15 mg intravitreal injection of MP0112 in the study eye.
|
MP0112 (0.4 mg)
n=6 Participants
Single 0.4 mg intravitreal injection of MP0112 in the study eye.
|
|---|---|---|---|
|
Number of Participants With Adverse Events as a Measure of Safety and Tolerability
Adverse Events (AEs)
|
3 Participants
|
6 Participants
|
6 Participants
|
|
Number of Participants With Adverse Events as a Measure of Safety and Tolerability
Serious Adverse Events
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events as a Measure of Safety and Tolerability
Ophthalmic AEs in the Study Eye
|
3 Participants
|
5 Participants
|
5 Participants
|
|
Number of Participants With Adverse Events as a Measure of Safety and Tolerability
Ophthalmic AEs in the Fellow Eye
|
1 Participants
|
3 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: Baseline, Week 16Population: All treated participants with data for a given time point were included for analysis.
BCVA was measured using an eye chart and was reported as the number of letters read correctly (ranging from 0 to 100 letters) in the study eye at Baseline and Week 16. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). The higher the letters read correctly on the eye chart the better the vision.
Outcome measures
| Measure |
MP0112 (0.04 mg)
n=6 Participants
Single 0.04 mg intravitreal injection of MP0112 in the study eye.
|
MP0112 (0.15 mg)
n=6 Participants
Single 0.15 mg intravitreal injection of MP0112 in the study eye.
|
MP0112 (0.4 mg)
n=6 Participants
Single 0.4 mg intravitreal injection of MP0112 in the study eye.
|
|---|---|---|---|
|
Best-Corrected Visual Acuity (BCVA)
Baseline (n=5,4,5)
|
56.2 Letters
Standard Deviation 9.8
|
59.0 Letters
Standard Deviation 4.8
|
59.6 Letters
Standard Deviation 17.1
|
|
Best-Corrected Visual Acuity (BCVA)
Week 16 (n=5,6,5)
|
66.8 Letters
Standard Deviation 12.9
|
55.5 Letters
Standard Deviation 10.0
|
66.0 Letters
Standard Deviation 17.5
|
SECONDARY outcome
Timeframe: Baseline, Week 16Population: All treated participants.
Optical Coherence Tomography (OCT), a laser based non-invasive diagnostic system providing high-resolution imaging sections of the fovea (part of the retina), was performed in the study eye after pupil dilation at Baseline and Week 16. A negative change from Baseline indicated improvement (less foveal thickness).
Outcome measures
| Measure |
MP0112 (0.04 mg)
n=6 Participants
Single 0.04 mg intravitreal injection of MP0112 in the study eye.
|
MP0112 (0.15 mg)
n=6 Participants
Single 0.15 mg intravitreal injection of MP0112 in the study eye.
|
MP0112 (0.4 mg)
n=6 Participants
Single 0.4 mg intravitreal injection of MP0112 in the study eye.
|
|---|---|---|---|
|
Change From Baseline in Foveal Thickness as Measured by Optical Coherence Tomography (OCT)
Baseline
|
390.5 microns
Standard Deviation 104.3
|
514.3 microns
Standard Deviation 146.0
|
402.0 microns
Standard Deviation 98.8
|
|
Change From Baseline in Foveal Thickness as Measured by Optical Coherence Tomography (OCT)
Change from Baseline at Week 16 (n=5,6,5)
|
-8.8 microns
Standard Deviation 78.4
|
-57.8 microns
Standard Deviation 170.3
|
-29.2 microns
Standard Deviation 96.0
|
SECONDARY outcome
Timeframe: 16 WeeksPopulation: All treated participants.
Blood samples were collected Pre-treatment (Baseline), Day 1 and 3, Weeks 1, 4, 12, 16. Serum samples (liquid portion of the blood after cells and clotting factors were removed) were sent to a laboratory for analysis. Levels of MP0112 were determined using an enzyme-linked immunosorbent assay.
Outcome measures
| Measure |
MP0112 (0.04 mg)
n=6 Participants
Single 0.04 mg intravitreal injection of MP0112 in the study eye.
|
MP0112 (0.15 mg)
n=6 Participants
Single 0.15 mg intravitreal injection of MP0112 in the study eye.
|
MP0112 (0.4 mg)
n=6 Participants
Single 0.4 mg intravitreal injection of MP0112 in the study eye.
|
|---|---|---|---|
|
Serum Levels of MP0112
|
NA Nanomolar (nM)
Result below Lower Limit of Quantification of the Assay =0.3 nM.
|
NA Nanomolar (nM)
Result below Lower Limit of Quantification of the Assay=0.3 nM.
|
NA Nanomolar (nM)
Result below Lower Limit of Quantification of the Assay=0.3 nM.
|
SECONDARY outcome
Timeframe: 1 WeekPopulation: All treated participants who consented to participate.
Aqueous humor (the thin, watery fluid in the eye) samples were collected from anterior chamber taps and were sent to a laboratory for analysis. Levels of MP0112 were determined using an enzyme-linked immunosorbent assay.
Outcome measures
| Measure |
MP0112 (0.04 mg)
n=3 Participants
Single 0.04 mg intravitreal injection of MP0112 in the study eye.
|
MP0112 (0.15 mg)
n=3 Participants
Single 0.15 mg intravitreal injection of MP0112 in the study eye.
|
MP0112 (0.4 mg)
n=4 Participants
Single 0.4 mg intravitreal injection of MP0112 in the study eye.
|
|---|---|---|---|
|
Aqueous Humor Levels of MP0112
|
14 nM
Interval 13.0 to 26.0
|
106 nM
Interval 26.0 to 270.0
|
555 nM
Interval 230.0 to 622.0
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: All treated participants.
Blood samples were collected Pre-treatment (Baseline) and Weeks 4, 8 and 12. Samples were analyzed for Anti-MP0112 antibodies using an enzyme-linked immunosorbent assay.
Outcome measures
| Measure |
MP0112 (0.04 mg)
n=6 Participants
Single 0.04 mg intravitreal injection of MP0112 in the study eye.
|
MP0112 (0.15 mg)
n=6 Participants
Single 0.15 mg intravitreal injection of MP0112 in the study eye.
|
MP0112 (0.4 mg)
n=6 Participants
Single 0.4 mg intravitreal injection of MP0112 in the study eye.
|
|---|---|---|---|
|
Number of Participants With Positive Binding Anti-MP0112 Antibodies
|
0 Participants
|
0 Participants
|
3 Participants
|
Adverse Events
MP0112 (0.04 mg)
MP0112 (0.15 mg)
MP0112 (0.4 mg)
Serious adverse events
| Measure |
MP0112 (0.04 mg)
n=6 participants at risk
Single 0.04 mg intravitreal injection of MP0112 in the study eye.
|
MP0112 (0.15 mg)
n=6 participants at risk
Single 0.15 mg intravitreal injection of MP0112 in the study eye.
|
MP0112 (0.4 mg)
n=6 participants at risk
Single 0.4 mg intravitreal injection of MP0112 in the study eye.
|
|---|---|---|---|
|
General disorders
Chest pain
|
0.00%
0/6
|
16.7%
1/6
|
0.00%
0/6
|
Other adverse events
| Measure |
MP0112 (0.04 mg)
n=6 participants at risk
Single 0.04 mg intravitreal injection of MP0112 in the study eye.
|
MP0112 (0.15 mg)
n=6 participants at risk
Single 0.15 mg intravitreal injection of MP0112 in the study eye.
|
MP0112 (0.4 mg)
n=6 participants at risk
Single 0.4 mg intravitreal injection of MP0112 in the study eye.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/6
|
0.00%
0/6
|
16.7%
1/6
|
|
Eye disorders
Conjunctival haemorrhage
|
33.3%
2/6
|
33.3%
2/6
|
50.0%
3/6
|
|
Eye disorders
Foreign body sensation in eyes
|
50.0%
3/6
|
33.3%
2/6
|
16.7%
1/6
|
|
Eye disorders
Anterior chamber flare
|
0.00%
0/6
|
0.00%
0/6
|
83.3%
5/6
|
|
Eye disorders
Eye pain
|
16.7%
1/6
|
33.3%
2/6
|
33.3%
2/6
|
|
Eye disorders
Iritis
|
0.00%
0/6
|
33.3%
2/6
|
33.3%
2/6
|
|
Eye disorders
Conjunctival hyperaemia
|
16.7%
1/6
|
16.7%
1/6
|
16.7%
1/6
|
|
Eye disorders
Eye irritation
|
16.7%
1/6
|
16.7%
1/6
|
16.7%
1/6
|
|
Eye disorders
Anterior chamber cell
|
0.00%
0/6
|
0.00%
0/6
|
33.3%
2/6
|
|
Eye disorders
Blepharitis
|
16.7%
1/6
|
0.00%
0/6
|
16.7%
1/6
|
|
Eye disorders
Conjunctival oedema
|
0.00%
0/6
|
33.3%
2/6
|
0.00%
0/6
|
|
Eye disorders
Photophobia
|
0.00%
0/6
|
33.3%
2/6
|
0.00%
0/6
|
|
Eye disorders
Retinal exudates
|
16.7%
1/6
|
0.00%
0/6
|
16.7%
1/6
|
|
Eye disorders
Vitreal cells
|
0.00%
0/6
|
0.00%
0/6
|
33.3%
2/6
|
|
Eye disorders
Vitreous floaters
|
0.00%
0/6
|
16.7%
1/6
|
16.7%
1/6
|
|
Eye disorders
Vitritis
|
0.00%
0/6
|
33.3%
2/6
|
0.00%
0/6
|
|
Eye disorders
Diabetic retinal oedema
|
0.00%
0/6
|
16.7%
1/6
|
0.00%
0/6
|
|
Eye disorders
Diabetic retinopathy
|
0.00%
0/6
|
0.00%
0/6
|
16.7%
1/6
|
|
Eye disorders
Eye pruritus
|
16.7%
1/6
|
0.00%
0/6
|
0.00%
0/6
|
|
Eye disorders
Iris adhesions
|
0.00%
0/6
|
16.7%
1/6
|
0.00%
0/6
|
|
Eye disorders
Iris atrophy
|
0.00%
0/6
|
16.7%
1/6
|
0.00%
0/6
|
|
Eye disorders
Lenticular pigmentation
|
0.00%
0/6
|
16.7%
1/6
|
0.00%
0/6
|
|
Eye disorders
Macular oedema
|
0.00%
0/6
|
0.00%
0/6
|
16.7%
1/6
|
|
Eye disorders
Ocular discomfort
|
0.00%
0/6
|
16.7%
1/6
|
0.00%
0/6
|
|
Eye disorders
Photopsia
|
0.00%
0/6
|
0.00%
0/6
|
16.7%
1/6
|
|
Eye disorders
Punctate keratitis
|
0.00%
0/6
|
0.00%
0/6
|
16.7%
1/6
|
|
Eye disorders
Retinal cyst
|
16.7%
1/6
|
0.00%
0/6
|
0.00%
0/6
|
|
Eye disorders
Retinal ischaemia
|
0.00%
0/6
|
16.7%
1/6
|
0.00%
0/6
|
|
Eye disorders
Retinal neovascularisation
|
0.00%
0/6
|
16.7%
1/6
|
0.00%
0/6
|
|
Eye disorders
Retinal pigment epitheliopathy
|
0.00%
0/6
|
16.7%
1/6
|
0.00%
0/6
|
|
Eye disorders
Vision blurred
|
0.00%
0/6
|
0.00%
0/6
|
16.7%
1/6
|
|
Eye disorders
Vitreous detachment
|
0.00%
0/6
|
16.7%
1/6
|
0.00%
0/6
|
|
Eye disorders
Vitreous fibrin
|
0.00%
0/6
|
0.00%
0/6
|
16.7%
1/6
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/6
|
0.00%
0/6
|
16.7%
1/6
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/6
|
16.7%
1/6
|
0.00%
0/6
|
|
Gastrointestinal disorders
Periodontal disease
|
0.00%
0/6
|
0.00%
0/6
|
16.7%
1/6
|
|
General disorders
Chest pain
|
0.00%
0/6
|
16.7%
1/6
|
0.00%
0/6
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/6
|
33.3%
2/6
|
16.7%
1/6
|
|
Infections and infestations
Cellulitis
|
0.00%
0/6
|
0.00%
0/6
|
16.7%
1/6
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.00%
0/6
|
0.00%
0/6
|
16.7%
1/6
|
|
Investigations
Blood creatine phosphokinase increased
|
16.7%
1/6
|
0.00%
0/6
|
0.00%
0/6
|
|
Investigations
Glycosylated haemoglobin increased
|
0.00%
0/6
|
16.7%
1/6
|
0.00%
0/6
|
|
Investigations
Paracentesis eye
|
0.00%
0/6
|
16.7%
1/6
|
0.00%
0/6
|
|
Investigations
Protein urine present
|
16.7%
1/6
|
0.00%
0/6
|
0.00%
0/6
|
|
Metabolism and nutrition disorders
Diabetes mellitus inadequate control
|
0.00%
0/6
|
0.00%
0/6
|
16.7%
1/6
|
|
Musculoskeletal and connective tissue disorders
Osteopenia
|
0.00%
0/6
|
16.7%
1/6
|
0.00%
0/6
|
|
Nervous system disorders
Headache
|
0.00%
0/6
|
0.00%
0/6
|
16.7%
1/6
|
|
Skin and subcutaneous tissue disorders
Skin mass
|
16.7%
1/6
|
0.00%
0/6
|
0.00%
0/6
|
|
Vascular disorders
Hypertension
|
0.00%
0/6
|
0.00%
0/6
|
16.7%
1/6
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
- Publication restrictions are in place
Restriction type: OTHER