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Diabetic Macular Edema (DME)Phase 2TIME-2NCT02050828

The TIME-2 Study: A Phase 2 Study of AKB-9778, a Novel Tie-2 Activator, in Patients With Diabetic Macular Edema

A Phase 2 study testing AKB-9778 and ranibizumab in people with Diabetic Macular Edema (DME), run by Aerpio Therapeutics at 39 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to evaluate the safety and efficacy of AKB-9778 administered as daily subcutaneous injections with and without monthly intravitreal injections of ranibizumab for 3 months in patients with diabetic macular edema. 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?
AKB-9778 and ranibizumab
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
144 participants
Where
39 sitesUnited States
Study dates
Jan 2014to May 2015
Phase
Phase 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

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 in the study eye determined to be primarily the result of DME
  • Definite retinal thickening due to diffuse DME involving the central macula in the study eye
  • Central subfield thickness of at least 325 µm by sdOCT with presence of intraretinal fluid in the study eye
  • ETDRS BCVA letter score ≤ 76 and ≥ 24 in the study eye

The following is an abbreviated list of exclusion criteria:

  • Hemoglobin A1C (HbA1C) ≥ 12.0% at Screening
  • History of non infectious uveitis
  • Decrease in visual acuity due to causes other than DME in the study eye
  • History of any of the following in the study eye (however, the following are not exclusionary in the fellow eye):
  1. Prior pars plana vitrectomy
  2. Any ocular surgery within 3 months prior to Day 1
  3. YAG capsulotomy within 3 months prior to Day 1
  4. Panretinal scatter photocoagulation (PRP) or focal laser within 3 months prior to Day 1 or anticipated need for PRP during the course of the study
  5. Prior intravitreal, subtenon, or periocular steroid therapy within 3 months prior to Day 1
  6. Prior treatment with intravitreal anti-vascular endothelial growth factor (VEGF) treatment within 8 weeks prior to Day 1

Trial locations and contacts

39 sites in 1 country.

39 sites in 1 country

United States39 sites

  • Study site

    Abilene, Texas, 79606

  • Study site

    Arcadia, California, 91007

  • Study site

    Austin, Texas, 78705

  • Study site

    Bakersfield, California, 93309

  • Study site

    Baltimore, Maryland, 21287

  • Study site

    Bellevue, Washington, 98004

  • Study site

    Beverly Hills, California, 90211

  • Study site

    Boynton Beach, Florida, 33426

  • Study site

    Charlotte, North Carolina, 28210

  • Study site

    Cincinnati, Ohio, 45242

  • Study site

    Cleveland, Ohio, 44195

  • Study site

    Florence, South Carolina, 29501

  • Study site

    Fort Lauderdale, Florida, 33334

  • Study site

    Fort Myers, Florida, 33912

  • Study site

    Fort Worth, Texas, 76102

  • Study site

    Golden, Colorado, 80401

  • Study site

    Houston, Texas, 77030

  • Study site

    Jackson, Michigan, 49202

  • Study site

    McAllen, Texas, 78503

  • Study site

    Miami, Florida, 33126

  • Study site

    Nashville, Tennessee, 37203

  • Study site

    Omaha, Nebraska, 68198

  • Study site

    Palm Desert, California, 92260

  • Study site

    Pheonix, Arizona, 85014

  • Study site

    Pheonix, Arizona, 85020

  • Study site

    Portland, Oregon, 97210

  • Study site

    Rapid City, South Dakota, 57701

  • Study site

    Reno, Nevada, 89502

  • Study site

    Rochester, New York, 14620

  • Study site

    Sacramento, California, 95819

  • Study site

    Salt Lake City, Utah, 84107

  • Study site

    San Antonio, Texas, 78240

  • Study site

    Santa Ana, California, 92705

  • Study site

    Santa Barbara, California, 93103

  • Study site

    Sarasota, Florida, 34239

  • Study site

    Stuart, Florida, 34994

  • Study site

    Tucson, Arizona, 85704

  • Study site

    Warrenton, Virginia, 20186

  • Study site

    Winter Haven, Florida, 33880

Other trials in United States

About this study

Official title: A Phase 2, Randomized, Active-Controlled, Double-Masked, Multi-Center Study to Assess the Safety and Efficacy of Daily Subcutaneous AKB-9778 Administered for 3 Months, as Monotherapy or Adjunctive to Ranibizumab, in Subjects With Diabetic Macular Edema

The purpose of this study is to evaluate the safety and efficacy of AKB-9778 administered as daily subcutaneous injections with and without monthly intravitreal injections of ranibizumab for 3 months in patients with diabetic macular edema.

Being tested
AKB-9778, ranibizumab, Placebo, Sham

What participants receive

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

  • AKB-9778Drug

  • ranibizumabDrug

    Also called Lucentis

  • PlaceboDrug

  • ShamDrug

Study groups in NCT02050828
Study groupRoleWhat they receive
AKB-9778 15 mg BID monotherapyExperimentalSubcutaneous AKB-9778 15 mg BID (total daily dose of 30 mg/day) plus monthly sham intravitreal injection for 3 months.
Receives: Drug: AKB-9778; Drug: Sham
AKB-9778 15 mg BID + ranibizumab 0.3 mgExperimentalSubcutaneous AKB-9778 15 mg BID (total daily dose of 30 mg/day) plus ranibizumab 0.3 mg monthly intravitreal injection for 3 months.
Receives: Drug: AKB-9778; Drug: ranibizumab
ranibizumab 0.3 mg monotherapyActive comparatorPlacebo subcutaneous injection (BID) plus ranibizumab 0.3 mg monthly intravitreal injection for 3 months.
Receives: Drug: ranibizumab; Drug: Placebo

What is being measured

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

  1. Mean change from baseline in spectral domain optical coherence tomography (sdOCT)-measured central subfield thickness (CST)

    Measured: Month 3

Secondary outcomes (1)

  1. Mean change from baseline in Early Treatment Diabetic Retinopathy Study (ETDRS) Best Corrected Visual Acuity (BCVA)

    Measured: Month 3

Timeline

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

  1. First posted31 Jan 2014 (estimated)
  2. Study startJan 2014
  3. Primary completionApr 2015
  4. Study completionMay 2015

Resources

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
144 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02050828
Sponsor's protocol ID
AKB-9778-CI-2003
Acronym
TIME-2
Status last verified
Mar 2017
First submitted
29 Jan 2014
Last updated
16 Mar 2017
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing AKB-9778 and ranibizumab in people with Diabetic Macular Edema (DME), run by Aerpio Therapeutics at 39 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?

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 16 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 39 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 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?

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?

Mean change from baseline in spectral domain optical coherence tomography (sdOCT)-measured central subfield thickness (CST) (time frame: Month 3). 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 NCT02050828.

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 16 Mar 2017.

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