Diabetic RetinopathyPhase 2NCT05038020

A Study to Evaluate the Efficacy of Oral AKST4290 in Participants With Moderately Severe to Severe Diabetic Retinopathy (CAPRI)

A Phase 2 study testing AKST4290 in people with Diabetic Retinopathy, run by Alkahest, Inc. at 17 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

A Double-Masked, Placebo-Controlled Study to Evaluate the Efficacy of Oral AKST4290 in Participants with Moderately Severe to Severe Diabetic Retinopathy (CAPRI). Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Diabetic Retinopathy
What is being tested?: AKST4290
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 3 participants
Where: 17 sitesUnited States
Study dates: 17 Aug 2021to 19 Apr 2022
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Age ≥ 18 years.
Type 1 or type 2 DM.
BCVA ETDRS visual acuity letter score≥ 69 letters at Screening.
Moderately severe NPDR (DRSS Level 47) to severe NPDR (DRSS Level 53).

Who cannot join

Evidence of neovascularization (NV) (including active iris or angle NV) requiring treatment, per investigator discretion.
PRP or grid laser within 1000 microns of the foveal center.
Center-InvolvedI-Diabetic Macular Edema (CI-DME) on clinical examination (CI is defined as DME within 1,000 microns of the foveal center).
Prior Intraocular of periocular steroid Injection
Systemic anti-VEGF or pro-VEGF treatment within 4 months prior to enrollment and assignment to a randomized treatment.
History of vitreoretinal surgery.

Show all 12Show fewer

History of major ocular surgery (including cataract extraction, scleral buckle, any intraocular surgery, etc.) within prior 4 months or anticipated within the next 6 months following randomization.
History of DME or DR treatment with laser or intraocular injections of medication.
Medical history or condition that, in the opinion of the investigator would preclude participation in the study.
Clinically relevant abnormal laboratory value at Screening, including hematology, blood chemistry, or urinalysis (laboratory testing may be repeated once during the Screening phase).
Malignancy for which the participant has undergone resection, radiation, or chemotherapy within the past 5 years (treated basal cell carcinoma or fully cured squamous cell carcinoma are allowed).
Concurrent participation in another interventional clinical trial; prior clinical trial participants must have been off study agents for at least 30 days for small molecules, 4 months for disease modifying therapies, and 1 year for vaccine or immunotherapy trials prior to Screening.

Trial locations and contacts

17 sites in 1 country.

City, postcode or hospital

17 sites in 1 country

United States17 sites

Site 122
Arlington, Texas, 76012
Site 133
Beaufort, South Carolina, 29902
Site 130
Bellaire, Texas, 77401
Site 116
Clearwater, Florida, 33761
Site 123
Glendale, California, 91203
Site 126
Harlingen, Texas, 78550
Site 134
Houston, Texas, 77025
Site 121
Huntington Beach, California, 92647
Site 129
Katy, Texas, 77494
Site 127
Ladson, South Carolina, 29456
Site 120
Oak Forest, Illinois, 60452
Site 132
Phoenix, Arizona, 85021
Site 136
Phoenix, Arizona, 85053
Site 125
Salt Lake City, Utah, 84107
Site 128
San Antonio, Texas, 78240
Site 117
Sarasota, Florida, 34239
Site 118
Winter Haven, Florida, 33880

Other trials in United States

About this study

Official title: A Double-Masked, Placebo-Controlled Study to Evaluate the Efficacy of Oral AKST4290 in Participants With Moderately Severe to Severe Diabetic Retinopathy (CAPRI)

A Double-Masked, Placebo-Controlled Study to Evaluate the Efficacy of Oral AKST4290 in Participants with Moderately Severe to Severe Diabetic Retinopathy (CAPRI).

Read the detailed description

This study is designed to evaluate the efficacy of AKST4290 administered at a total daily dose (TDD) of 800 mg daily (400 mg twice daily [b.i.d.]) compared with placebo over a 24-week dosing period in participants with moderately severe non-proliferative diabetic retinopathy (NPDR) to severe NPDR.

Participants will be enrolled and allocated to 1 of 2 treatment arms in a 2:1 randomization scheme (AKST4290: placebo). Participants will receive treatment for a total of 24 weeks with either AKST4290 800 mg daily (400 mg b.i.d.) in Arm 1 or placebo (matching tablets) in Arm 2

Conditions: Diabetic Retinopathy
Being tested: AKST4290, Placebo
Keywords: CCR3 inhibition, Diabetic Retinopathy, Oral Treatment
Medical subject headings: Diabetic Retinopathy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

AKST4290Drug
Oral AKST4290
PlaceboDrug
Oral Placebo

Study groups in NCT05038020
Study group	Role	What they receive
AKST4290	Experimental	Subjects will receive AKST4290, 400mg twice daily, for 24 weeks Receives: Drug: AKST4290
Placebo	Placebo comparator	Subjects will receive matching Placebo, twice daily, for 24 weeks Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

To Investigate the Efficacy of AKST4290 Assessed by the Improvement in the DRSS Score From Baseline.
The Diabetic Retinopathy Severity Scale (DRSS) divides DR into 13 levels ranging from the absence of retinopathy to severe retinopathy and is used to describe overall DR severity as well as the change in severity over time. Higher scores indicate more severe DR.
To be eligible for the study, participants needed to have moderately severe non-proliferative DR (NPDR) (DRSS Level 47) to severe NPDR (DRSS Level 53) in one eye, and at least mild NPDR (DRSS Level 35) to mild proliferative DR (PDR) (DRSS Level 61) in the other eye at baseline.
The DRSS score is derived from fundus photography (FP) and fluorescein angiography (FA) findings.
The primary efficacy endpoint is the proportion of participants with a ≥ 3-step improvement from baseline on the DRSS score as compared with Week 24.
Measured: Baseline to Week 24

Secondary outcomes (6)

To Investigate Additional Measures of Efficacy of AKST4290 Assessed by the Improvement in the DRSS Score From Baseline.
The Diabetic Retinopathy Severity Scale (DRSS) divides DR into 13 levels ranging from the absence of retinopathy to severe retinopathy and is used to describe overall DR severity as well as the change in severity over time. Higher scores indicate more severe DR.
The DRSS score is derived from fundus photography (FP) and fluorescein angiography (FA) findings.
The secondary efficacy endpoint is the proportion of participants with a ≥ 2-step improvement from baseline on the DRSS score as compared with Week 24.
Measured: Baseline to Week 24 or 28
To Assess the Proportion of Participants Progressing to (or Worsening of) Center-involved Diabetic Macular Edema (CI-DME), Proliferative Diabetic Retinopathy (PDR), and/or Anterior-segment Neovascularization (ASNV).
The secondary efficacy endpoint is the proportion of participants progressing to the following vision-threatening complications that require treatment: CI-DME, PDR, and/or ASNV as assessed by spectral domain optical coherence tomography (SD-OCT), fundus photography (FP), and fluorescein angiography (FA), as appropriate. The central reading center must confirm progression to CI-DME and PDR before treatment is initiated; progression to ASNV, and subsequent treatment, does not require photo documentation.
Measured: Baseline to Week 28
To Assess the Time to Event of CI-DME, PDR, and/or ASNV Requiring Treatment.
The secondary efficacy endpoint is the time to the following vision-threatening event(s) that require treatment: CI-DME, PDR, and/or ASNV
Measured: Baseline to Week 28
To Assess the Overall Safety of AKST429
Safety was assessed based on the number of participants who reported adverse events of mild, moderate or severe intensities.
Measured: Baseline to Week 28
To Assess the Effect of AKST4290 on Diabetic Kidney Disease
The secondary efficacy endpoint is the effect of AKST4290 on diabetic kidney disease as assessed by changes in clinical laboratory values over time (eg, estimated glomerular filtration rate [eGFR], urine albumin to creatinine ratio [UACR]).
Measured: Baseline to Week 28
To Evaluate the Changes From Baseline in the Workplace Productivity and Activity Impairment General Health (WPAI-GH) Questionnaire.
The WPAI-GH V2.0 is a 6-question survey used to assess the effects of a participant's health problems (i.e., physical or emotional problems or symptoms) on their ability to work and perform regular activities during the past seven days. The WPAI-GH questions will be analyzed as impairment percentages, in which higher percentages indicate greater impairment and less productivity.
The following parameters will be calculated (multiply scores by 100 to express in percentages):
- Percent of work time missed due to health: Q2 divided by (Q2 plus Q4)
- Percent of impairment while working due to health: Q5 divided by 10
- Percent of overall work impairment due to health: Q2 divided by (Q2 plus Q4) plus [(1 - (Q2 divided by (Q2 plus Q4 ))) multiplied by (Q5 divided by 10)]
- Percent of activity impairment due to health: Q6 divided by 10
Measured: Baseline to Week 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

17 Aug 202119 Apr 2022

First posted8 Sep 2021
Study start17 Aug 2021
Primary completion9 Dec 2021
Study completion19 Apr 2022

Why it stopped: Study terminated due to safety findings in other AKST4290 studies

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Diabetic RetinopathyStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 3 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05038020
Sponsor's protocol ID: AKST4290-231
Status last verified: Oct 2023
First submitted: 29 Jul 2021
Last updated: 1 Nov 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Diabetic Retinopathy trials

Study at a glance

From the registry record, last updated by the sponsor on 1 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Double-Masked, Placebo-Controlled Study to Evaluate the Efficacy of Oral AKST4290 in Participants With Moderately Severe to Severe Diabetic Retinopathy (CAPRI)
ClinicalTrials.gov ID: NCT05038020
Acronym / sponsor ID: AKST4290-231
Conditions: Diabetic Retinopathy
Keywords: CCR3 inhibition, Diabetic Retinopathy, Oral Treatment
Phase: Phase 2
Study type: Interventional
Recruitment status: TerminatedReason stopped: Study terminated due to safety findings in other AKST4290 studies
Enrolment: 3 participants (actual)
Lead sponsor: Alkahest, Inc.Industry (pharma, biotech, devices)
Study start: 17 Aug 2021 (actual)
Primary completion: 9 Dec 2021 (actual)
Study completion: 19 Apr 2022 (actual)
First posted: 8 Sep 2021 (actual)
Results: Posted 1 Nov 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

A Double-Masked, Placebo-Controlled Study to Evaluate the Efficacy of Oral AKST4290 in Participants with Moderately Severe to Severe Diabetic Retinopathy (CAPRI).

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
AKST4290	Experimental	Drug: AKST4290Subjects will receive AKST4290, 400mg twice daily, for 24 weeks
Placebo	Placebo comparator	Drug: PlaceboSubjects will receive matching Placebo, twice daily, for 24 weeks

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Age ≥ 18 years.
Type 1 or type 2 DM.
BCVA ETDRS visual acuity letter score≥ 69 letters at Screening.
Moderately severe NPDR (DRSS Level 47) to severe NPDR (DRSS Level 53).

Key exclusion criteria (12 listed)

Evidence of neovascularization (NV) (including active iris or angle NV) requiring treatment, per investigator discretion.
PRP or grid laser within 1000 microns of the foveal center.
Center-InvolvedI-Diabetic Macular Edema (CI-DME) on clinical examination (CI is defined as DME within 1,000 microns of the foveal center).
Prior Intraocular of periocular steroid Injection
Systemic anti-VEGF or pro-VEGF treatment within 4 months prior to enrollment and assignment to a randomized treatment.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
AKST4290Oral AKST4290	Drug	AKST4290
PlaceboOral Placebo	Drug	Placebo

Primary outcome

To Investigate the Efficacy of AKST4290 Assessed by the Improvement in the DRSS Score From Baseline.
Time frame: Baseline to Week 24
The Diabetic Retinopathy Severity Scale (DRSS) divides DR into 13 levels ranging from the absence of retinopathy to severe retinopathy and is used to describe overall DR severity as well as the change in severity over time. Higher scores indicate more severe DR. To be eligible for the study, participants needed to have moderately severe non-proliferative DR (NPDR) (DRSS Level 47) to severe NPDR (DRSS Level 53) in one eye, and at least mild NPDR (DRSS Level 35) to mild proliferative DR (PDR) (DRSS Level 61) in the other eye at baseline. The DRSS score is derived from fundus photography (FP) and fluorescein angiography (FA) findings. The primary efficacy endpoint is the proportion of participants with a ≥ 3-step improvement from baseline on the DRSS score as compared with Week 24.

6 secondary outcomes

To Investigate Additional Measures of Efficacy of AKST4290 Assessed by the Improvement in the DRSS Score From Baseline.
Time frame: Baseline to Week 24 or 28
To Assess the Proportion of Participants Progressing to (or Worsening of) Center-involved Diabetic Macular Edema (CI-DME), Proliferative Diabetic Retinopathy (PDR), and/or Anterior-segment Neovascularization (ASNV).
Time frame: Baseline to Week 28
To Assess the Time to Event of CI-DME, PDR, and/or ASNV Requiring Treatment.
Time frame: Baseline to Week 28
To Assess the Overall Safety of AKST429
Time frame: Baseline to Week 28
To Assess the Effect of AKST4290 on Diabetic Kidney Disease
Time frame: Baseline to Week 28
To Evaluate the Changes From Baseline in the Workplace Productivity and Activity Impairment General Health (WPAI-GH) Questionnaire.
Time frame: Baseline to Week 24

Results and safety

Results posted to the registry on 1 Nov 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
AKST4290	3	0
Placebo	0	0

Primary outcome: To Investigate the Efficacy of AKST4290 Assessed by the Improvement in the DRSS Score From Baseline.

Time frame: Baseline to Week 24

Population analysed: The study was terminated by the Sponsor. Only 3 participants were enrolled in this study. Based on the low enrollment number, no data is reported here in order to protect and maintain participant privacy/confidentiality.

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: The planned timeframe for adverse event (AE) collection was from the first dose of the study drug until the post-treatment follow-up period (baseline to Week 28). However, the study was terminated early by the sponsor. At the time of termination, 3 participants were enrolled and none completed the study. Enrolled subjects had a safety visit at 30 and 60 days following study drug discontinuation.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
AKST4290	0 of 3 (0%)	2 of 3 (66.7%)	0 of 3
Placebo	0 of 0	0 of 0	0

Limitations and caveats (from the sponsor): This study was terminated by the Sponsor. Only 3 participants were enrolled in this study. Based on low enrollment number, no data is reported in order to protect and maintain participant privacy/confidentiality.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Alkahest Medical Monitor study director

Alkahest, Inc.

17 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing AKST4290 in people with Diabetic Retinopathy, run by Alkahest, Inc. at 17 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 1 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 17 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 1 Nov 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

To Investigate the Efficacy of AKST4290 Assessed by the Improvement in the DRSS Score From Baseline. (time frame: Baseline to Week 24). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05038020.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2023.