Diabetic Macular Edema (DME)Phase 1/2NCT01702441
Safety and Pilot Efficacy of AKB-9778 in Subjects With Diabetic Macular Edema
A Phase 1/2 study testing Subcutaneous AKB-9778 in people with Diabetic Macular Edema (DME), run by Aerpio Therapeutics at 6 sites in United States.
Trial summary
The purpose of this study is to evaluate the safety, pharmacokinetics, pharmacodynamics, and pilot efficacy of multiple ascending dose levels of AKB-9778 given as subcutaneous injections daily for 28 days in patients with diabetic macular edema (DME). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Diabetic Macular Edema (DME)
- What is being tested?
- Subcutaneous AKB-9778
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 6 sitesUnited States
- Study dates
- Sep 2012to Dec 2014
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The following is an abbreviated list of inclusion criteria:
- Adults between 18 to 80 years of age, inclusive
- Diagnosis of diabetes mellitus (type 1 or type 2)
- Decrease in vision determined to be primarily the result of DME in the study eye
- Definite Retinal thickening due to diffuse DME involving the center of the macula in the study eye
- Mean central subfield thickness of at least 325 µm by OCT in the study eye
- Early Treatment Diabetic Retinopathy Study (ETDRS) letter score BCVA ≤ 70 (20/40) in the study eye
Who cannot join
- The following is an abbreviated list of exclusion criteria:
- Hemoglobin A1C (HbA1C) ≥ 11.5%
- History of any of the following in the study eye (however, the following are not exclusionary in the fellow eye):
- Panretinal scatter photocoagulation (PRP) or focal laser within 12 weeks prior to Screening
- Prior pars plana vitrectomy within 12 weeks prior to Screening
- Any ocular surgery within 12 weeks prior to Screening
- YAG capsulotomy within 7 days prior to Screening
- Prior intravitreal, subtenon, or periocular steroid therapy within 3 months prior to Screening or prior treatment with intravitreal anti-VEGF treatment within 1 month of Screening
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Study site
Baltimore, Maryland
Study site
Beverly Hills, California
Study site
Boston, Massachusetts
Study site
Charlotte, North Carolina
Study site
Cincinnati, Ohio
Study site
Winter Haven, Florida
About this study
Official title: Phase 1b/2a Open Label, Multiple-Ascending Dose Cohort Study to Assess the Safety, Tolerability, Pilot Efficacy, Pharmacokinetics and Pharmacodynamic Effects of 28 Day Repeat Subcutaneous Doses of AKB-9778 in Subjects With Diabetic Macular Edema
The purpose of this study is to evaluate the safety, pharmacokinetics, pharmacodynamics, and pilot efficacy of multiple ascending dose levels of AKB-9778 given as subcutaneous injections daily for 28 days in patients with diabetic macular edema (DME).
- Conditions
- Diabetic Macular Edema (DME)
- Being tested
- Subcutaneous AKB-9778
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Subcutaneous AKB-9778Drug
| Study group | Role | What they receive |
|---|---|---|
| AKB-9778 | Experimental | Up to 4 dose levels of subcutaneous AKB-9778 will be evaluated. Doses will be administered daily for 28 days. Receives: Drug: Subcutaneous AKB-9778 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and severity of adverse events (AEs).
Measured: 28 days
Change from baseline in physical exams.
Measured: 28 days
Change from baseline in vital signs.
Measured: 28 days
Change from baseline in electrocardiograms (ECGs).
Measured: 28 days
Change from baseline in opthalmic exams.
Measured: 28 days
Change from baseline in clinical laboratory assay results.
Blood chemistry, hematology and urinalysis.
Measured: 28 days
Secondary outcomes (3)
Pharmacokinetics of AKB-9778
Maximum plasma drug concentration (Cmax). Area under the plasma concentration-time curve (AUC).
Measured: Day 1 and Day 14
Change from baseline in optical tomography (OCT)-measured retinal thickness.
Measured: 28 days
Change from baseline in best corrected visual acuity (BCVA).
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2012 (estimated)
- Study startSep 2012
- Primary completionSep 2013
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Macular Edema (DME)Studies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aerpio Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kevin Peters, MD, Study director, Aerpio Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01702441
- Sponsor's protocol ID
- AKB-9778-CI-2002
- Status last verified
- Mar 2015
- First submitted
- 24 Sep 2012
- Last updated
- 27 Mar 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1b/2a Open Label, Multiple-Ascending Dose Cohort Study to Assess the Safety, Tolerability, Pilot Efficacy, Pharmacokinetics and Pharmacodynamic Effects of 28 Day Repeat Subcutaneous Doses of AKB-9778 in Subjects With Diabetic Macular Edema
- ClinicalTrials.gov ID
- NCT01702441
- Acronym / sponsor ID
- AKB-9778-CI-2002
- Conditions
- Diabetic Macular Edema (DME)
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Aerpio TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- Sep 2012
- Primary completion
- Sep 2013 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 8 Oct 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the safety, pharmacokinetics, pharmacodynamics, and pilot efficacy of multiple ascending dose levels of AKB-9778 given as subcutaneous injections daily for 28 days in patients with diabetic macular edema (DME).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AKB-9778 | Experimental | Drug: Subcutaneous AKB-9778Up to 4 dose levels of subcutaneous AKB-9778 will be evaluated. Doses will be administered daily for 28 days. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Adults between 18 to 80 years of age, inclusive
- Diagnosis of diabetes mellitus (type 1 or type 2)
- Decrease in vision determined to be primarily the result of DME in the study eye
- Definite Retinal thickening due to diffuse DME involving the center of the macula in the study eye
- Mean central subfield thickness of at least 325 µm by OCT in the study eye
Key exclusion criteria (8 listed)
- Hemoglobin A1C (HbA1C) ≥ 11.5%
- History of any of the following in the study eye (however, the following are not exclusionary in the fellow eye):
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 |
|---|---|---|
| Subcutaneous AKB-9778 | Drug | AKB-9778 |
Primary outcome
Incidence and severity of adverse events (AEs).
Time frame: 28 days
Change from baseline in physical exams.
Time frame: 28 days
Change from baseline in vital signs.
Time frame: 28 days
Change from baseline in electrocardiograms (ECGs).
Time frame: 28 days
Change from baseline in opthalmic exams.
Time frame: 28 days
Change from baseline in clinical laboratory assay results.
Time frame: 28 days
Blood chemistry, hematology and urinalysis.
3 secondary outcomes
Pharmacokinetics of AKB-9778
Time frame: Day 1 and Day 14
Change from baseline in optical tomography (OCT)-measured retinal thickness.
Time frame: 28 days
Change from baseline in best corrected visual acuity (BCVA).
Time frame: 28 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2015.
Related trials for Diabetic Macular Edema (DME)
RecruitingPhase 3
A Phase 3 Trial for Intravitreal Injection of 4D-150 in Adults With Diabetic Macular Edema (DME).
Diabetic Macular Edema (DME)
RecruitingPhase 2
Oral N-Acetylcysteine on Diabetic Macular Edema
Diabetic Macular Edema (DME)
Active, not recruitingPhase 3
COMO: A Phase 3 Randomized, Double-Masked Study Comparing the Efficacy of EYP-1901 Against Aflibercept in DME
Diabetic Macular Edema, DME
RecruitingPhase 3
A Clinical Trial of MK-8748 Compared to Aflibercept in Participants With Diabetic Macular Edema (MK-8748-005)
Diabetic Retinopathy, Macular Edema
RecruitingPhase 3
A Clinical Trial of MK-8748 Compared to Aflibercept in Participants With Diabetic Macular Edema (MK-8748-004)
Diabetic Retinopathy, Macular Edema
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.
Kevin Peters, MD study director
Aerpio Therapeutics
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Subcutaneous AKB-9778 in people with Diabetic Macular Edema (DME), run by Aerpio Therapeutics at 6 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 7 inclusion and 8 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: finished, as of the sponsor's last update on 27 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Incidence and severity of adverse events (AEs). (time frame: 28 days). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Mar 2015.