Trial Outcomes & Findings for Evaluate the Effects and Safety of ALK4290 in Patients With Newly Diagnosed Wet Age-Related Macular Degeneration (NCT NCT03558061)

Last Updated: 2020-12-16

Results Overview

Mean change in BCVA letter score as measured by the Early Treatment Diabetic Retinopathy Study (ETDRS) method. The ETDRS chart assesses changes in vision based on the number of letters correctly read by the subject.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

30 participants

Primary outcome timeframe

Baseline to 6 weeks

Results posted on

2020-12-16

Participant Flow

Participant milestones

Participant milestones
Measure	Active ALK4290 800 mg daily
Overall Study STARTED	30
Overall Study COMPLETED	29
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Evaluate the Effects and Safety of ALK4290 in Patients With Newly Diagnosed Wet Age-Related Macular Degeneration

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Active n=30 Participants ALK4290 800 mg daily
Age, Continuous	73.1 years STANDARD_DEVIATION 8.78 • n=5 Participants
Sex: Female, Male Female	18 Participants n=5 Participants
Sex: Female, Male Male	12 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	30 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	30 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment Hungary	8 participants n=5 Participants
Region of Enrollment Poland	22 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline to 6 weeks

Population: Evaluable Set

Outcome measures

Outcome measures
Measure	Active n=29 Participants ALK4290 800 mg daily
Best Corrected Visual Acuity (BCVA)	7.0 letters Standard Deviation 12.51

SECONDARY outcome

Timeframe: Baseline to 10 weeks

Population: Safety Set

Treatment-emergent adverse events identified by the Common Terminology Criteria for Adverse Events (CTCAE v4.03)

Outcome measures

Outcome measures
Measure	Active n=30 Participants ALK4290 800 mg daily
Incidence of Treatment-emergent Adverse Events (Safety)	14 Participants

Adverse Events

Active

Serious events: 0 serious events

Other events: 14 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Active n=30 participants at risk ALK4290 800 mg daily
Eye disorders Visual acuity reduced	6.7% 2/30 • Number of events 2 • 11 weeks
Musculoskeletal and connective tissue disorders Arthralgia	16.7% 5/30 • Number of events 7 • 11 weeks
Musculoskeletal and connective tissue disorders Back pain	10.0% 3/30 • Number of events 3 • 11 weeks
Infections and infestations Cystitis	6.7% 2/30 • Number of events 2 • 11 weeks
Nervous system disorders Headache	6.7% 2/30 • Number of events 3 • 11 weeks

Additional Information

Head of Communications

Alkahest, Inc.

Phone: (650) 801-0474

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60