Trial Outcomes & Findings for A Study to Evaluate THR-687 Treatment for Diabetic Macular Oedema. (NCT NCT05063734)
NCT ID: NCT05063734
Last Updated: 2023-08-18
Results Overview
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
16 participants
Primary outcome timeframe
At Month 3
Results posted on
2023-08-18
Participant Flow
Participant milestones
| Measure |
Part A, THR-687 1.2mg
THR-687: 3 intravitreal injections of THR-687, 1 month apart
|
Part A, THR-687 2.0mg
THR-687: 3 intravitreal injections of THR-687, 1 month apart
|
|---|---|---|
|
Overall Study
STARTED
|
7
|
9
|
|
Overall Study
COMPLETED
|
6
|
9
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study to Evaluate THR-687 Treatment for Diabetic Macular Oedema.
Baseline characteristics by cohort
| Measure |
Part A, THR-687 1.2mg
n=7 Participants
THR-687: 3 intravitreal injections of THR-687, 1 month apart
|
Part A, THR-687 2.0mg
n=9 Participants
THR-687: 3 intravitreal injections of THR-687, 1 month apart
|
Total
n=16 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
67.3 years
STANDARD_DEVIATION 13.61 • n=5 Participants
|
59.0 years
STANDARD_DEVIATION 9.55 • n=7 Participants
|
62.6 years
STANDARD_DEVIATION 11.87 • n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: At Month 3Population: Part B of the study was not initiated due to insufficient evidence of efficacy based on the data obtained in Part A
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: at Month 3Population: Part B of the study was not initiated due to insufficient evidence of efficacy based on the data obtained in Part A
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to Month 8Population: Part B of the study was not initiated due to insufficient evidence of efficacy based on the data obtained in Part A
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to Month 8Population: Part B of the study was not initiated due to insufficient evidence of efficacy based on the data obtained in Part A
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to End of Study (Part A up to Month 6 and Part B up to Month 8)Adverse Events will be reported from the date of Informed Consent until End of the Study visit (up to Month 6 in Part A and up to Month 8 in Part B) or at the early study discontinuation visit and will be coded using MedDRA. Adverse Events will be summarized by System Organ Class and Primary Term. Incidence by subject represents at least one occurrence of the Primary Term with an onset on or after the date of the first study treatment. If a subject has multiple occurrences of an adverse event (P-term), the subject is presented only once in the respective subject count.
Outcome measures
| Measure |
Part B, Treatment naïve Subjects, THR-687 Selected Dose Level
n=7 Participants
3 intravitreal injections of THR-687 selected dose level, 1 month apart, possibly followed by a 4th intravitreal injection with the same dose level of THR-687 at Month 3, or Month 4, or Month 5, if any of the PRN criteria are met
|
Part B, Treatment naïve Subjects, Aflibercept
n=9 Participants
3 intravitreal injections of aflibercept, 1 month apart, possibly followed by a 4th intravitreal injection with aflibercept at Month 3, or Month 4, or Month 5, if any of the PRN criteria are met
|
|---|---|---|
|
Incidence of Ocular and Non-ocular Adverse Events (AEs) and Serious Adverse Events (SAEs)
|
4 Participants
|
6 Participants
|
Adverse Events
Part A, THR-687 1.2mg
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Part A, THR-687 2.0mg
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Part A, THR-687 1.2mg
n=7 participants at risk
THR-687: 3 intravitreal injections of THR-687, 1 month apart
|
Part A, THR-687 2.0mg
n=9 participants at risk
THR-687: 3 intravitreal injections of THR-687, 1 month apart
|
|---|---|---|
|
Eye disorders
Cataract Subcapsular
|
0.00%
0/7 • Up to End of Study (up to Month 6 for Part A and up to Month 8 for Part B)
All Adverse Events were collected from the time the subject provided consent to participate in the study until the end of the study (last study visit) for the subject.
|
11.1%
1/9 • Number of events 1 • Up to End of Study (up to Month 6 for Part A and up to Month 8 for Part B)
All Adverse Events were collected from the time the subject provided consent to participate in the study until the end of the study (last study visit) for the subject.
|
|
Eye disorders
Diabetic Retinal Oedema
|
0.00%
0/7 • Up to End of Study (up to Month 6 for Part A and up to Month 8 for Part B)
All Adverse Events were collected from the time the subject provided consent to participate in the study until the end of the study (last study visit) for the subject.
|
11.1%
1/9 • Number of events 1 • Up to End of Study (up to Month 6 for Part A and up to Month 8 for Part B)
All Adverse Events were collected from the time the subject provided consent to participate in the study until the end of the study (last study visit) for the subject.
|
|
Eye disorders
Optic Disc Haemorrhage
|
0.00%
0/7 • Up to End of Study (up to Month 6 for Part A and up to Month 8 for Part B)
All Adverse Events were collected from the time the subject provided consent to participate in the study until the end of the study (last study visit) for the subject.
|
11.1%
1/9 • Number of events 1 • Up to End of Study (up to Month 6 for Part A and up to Month 8 for Part B)
All Adverse Events were collected from the time the subject provided consent to participate in the study until the end of the study (last study visit) for the subject.
|
|
Eye disorders
Posterior Capsule Opacification
|
0.00%
0/7 • Up to End of Study (up to Month 6 for Part A and up to Month 8 for Part B)
All Adverse Events were collected from the time the subject provided consent to participate in the study until the end of the study (last study visit) for the subject.
|
11.1%
1/9 • Number of events 1 • Up to End of Study (up to Month 6 for Part A and up to Month 8 for Part B)
All Adverse Events were collected from the time the subject provided consent to participate in the study until the end of the study (last study visit) for the subject.
|
|
Eye disorders
Retinal Thickening
|
0.00%
0/7 • Up to End of Study (up to Month 6 for Part A and up to Month 8 for Part B)
All Adverse Events were collected from the time the subject provided consent to participate in the study until the end of the study (last study visit) for the subject.
|
33.3%
3/9 • Number of events 3 • Up to End of Study (up to Month 6 for Part A and up to Month 8 for Part B)
All Adverse Events were collected from the time the subject provided consent to participate in the study until the end of the study (last study visit) for the subject.
|
|
Eye disorders
Visual Acuity Reduced
|
14.3%
1/7 • Number of events 1 • Up to End of Study (up to Month 6 for Part A and up to Month 8 for Part B)
All Adverse Events were collected from the time the subject provided consent to participate in the study until the end of the study (last study visit) for the subject.
|
33.3%
3/9 • Number of events 3 • Up to End of Study (up to Month 6 for Part A and up to Month 8 for Part B)
All Adverse Events were collected from the time the subject provided consent to participate in the study until the end of the study (last study visit) for the subject.
|
|
Infections and infestations
COVID-19
|
0.00%
0/7 • Up to End of Study (up to Month 6 for Part A and up to Month 8 for Part B)
All Adverse Events were collected from the time the subject provided consent to participate in the study until the end of the study (last study visit) for the subject.
|
11.1%
1/9 • Number of events 1 • Up to End of Study (up to Month 6 for Part A and up to Month 8 for Part B)
All Adverse Events were collected from the time the subject provided consent to participate in the study until the end of the study (last study visit) for the subject.
|
|
Infections and infestations
Gastroenteritis Viral
|
14.3%
1/7 • Number of events 1 • Up to End of Study (up to Month 6 for Part A and up to Month 8 for Part B)
All Adverse Events were collected from the time the subject provided consent to participate in the study until the end of the study (last study visit) for the subject.
|
0.00%
0/9 • Up to End of Study (up to Month 6 for Part A and up to Month 8 for Part B)
All Adverse Events were collected from the time the subject provided consent to participate in the study until the end of the study (last study visit) for the subject.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/7 • Up to End of Study (up to Month 6 for Part A and up to Month 8 for Part B)
All Adverse Events were collected from the time the subject provided consent to participate in the study until the end of the study (last study visit) for the subject.
|
11.1%
1/9 • Number of events 1 • Up to End of Study (up to Month 6 for Part A and up to Month 8 for Part B)
All Adverse Events were collected from the time the subject provided consent to participate in the study until the end of the study (last study visit) for the subject.
|
|
Investigations
Intraocular Pressure Increased
|
0.00%
0/7 • Up to End of Study (up to Month 6 for Part A and up to Month 8 for Part B)
All Adverse Events were collected from the time the subject provided consent to participate in the study until the end of the study (last study visit) for the subject.
|
11.1%
1/9 • Number of events 2 • Up to End of Study (up to Month 6 for Part A and up to Month 8 for Part B)
All Adverse Events were collected from the time the subject provided consent to participate in the study until the end of the study (last study visit) for the subject.
|
|
Metabolism and nutrition disorders
Diabetes Mellitus
|
0.00%
0/7 • Up to End of Study (up to Month 6 for Part A and up to Month 8 for Part B)
All Adverse Events were collected from the time the subject provided consent to participate in the study until the end of the study (last study visit) for the subject.
|
11.1%
1/9 • Number of events 1 • Up to End of Study (up to Month 6 for Part A and up to Month 8 for Part B)
All Adverse Events were collected from the time the subject provided consent to participate in the study until the end of the study (last study visit) for the subject.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/7 • Up to End of Study (up to Month 6 for Part A and up to Month 8 for Part B)
All Adverse Events were collected from the time the subject provided consent to participate in the study until the end of the study (last study visit) for the subject.
|
11.1%
1/9 • Number of events 1 • Up to End of Study (up to Month 6 for Part A and up to Month 8 for Part B)
All Adverse Events were collected from the time the subject provided consent to participate in the study until the end of the study (last study visit) for the subject.
|
|
Nervous system disorders
Cerebrovascular Accident
|
14.3%
1/7 • Number of events 1 • Up to End of Study (up to Month 6 for Part A and up to Month 8 for Part B)
All Adverse Events were collected from the time the subject provided consent to participate in the study until the end of the study (last study visit) for the subject.
|
0.00%
0/9 • Up to End of Study (up to Month 6 for Part A and up to Month 8 for Part B)
All Adverse Events were collected from the time the subject provided consent to participate in the study until the end of the study (last study visit) for the subject.
|
|
Reproductive system and breast disorders
Genital Disorder
|
14.3%
1/7 • Number of events 1 • Up to End of Study (up to Month 6 for Part A and up to Month 8 for Part B)
All Adverse Events were collected from the time the subject provided consent to participate in the study until the end of the study (last study visit) for the subject.
|
0.00%
0/9 • Up to End of Study (up to Month 6 for Part A and up to Month 8 for Part B)
All Adverse Events were collected from the time the subject provided consent to participate in the study until the end of the study (last study visit) for the subject.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
14.3%
1/7 • Number of events 1 • Up to End of Study (up to Month 6 for Part A and up to Month 8 for Part B)
All Adverse Events were collected from the time the subject provided consent to participate in the study until the end of the study (last study visit) for the subject.
|
0.00%
0/9 • Up to End of Study (up to Month 6 for Part A and up to Month 8 for Part B)
All Adverse Events were collected from the time the subject provided consent to participate in the study until the end of the study (last study visit) for the subject.
|
|
Vascular disorders
Hypertension
|
14.3%
1/7 • Number of events 1 • Up to End of Study (up to Month 6 for Part A and up to Month 8 for Part B)
All Adverse Events were collected from the time the subject provided consent to participate in the study until the end of the study (last study visit) for the subject.
|
22.2%
2/9 • Number of events 2 • Up to End of Study (up to Month 6 for Part A and up to Month 8 for Part B)
All Adverse Events were collected from the time the subject provided consent to participate in the study until the end of the study (last study visit) for the subject.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place