Trial record 2 of 3 for:
Tie2 and diabetic
The TIME-2 Study: A Phase 2 Study of AKB-9778, a Novel Tie-2 Activator, in Patients With Diabetic Macular Edema (TIME-2)
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT02050828 |
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Recruitment Status :
Completed
First Posted : January 31, 2014
Last Update Posted : March 16, 2017
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Sponsor:
Aerpio Therapeutics
Information provided by (Responsible Party):
Aerpio Therapeutics
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Brief 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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Diabetic Macular Edema (DME) | Drug: AKB-9778 Drug: ranibizumab Drug: Placebo Drug: Sham | Phase 2 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 144 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| 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 |
| Study Start Date : | January 2014 |
| Actual Primary Completion Date : | April 2015 |
| Actual Study Completion Date : | May 2015 |
Resource links provided by the National Library of Medicine
MedlinePlus related topics:
Edema
Drug Information available for:
Ranibizumab
| Arm | Intervention/treatment |
|---|---|
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Experimental: AKB-9778 15 mg BID monotherapy
Subcutaneous AKB-9778 15 mg BID (total daily dose of 30 mg/day) plus monthly sham intravitreal injection for 3 months.
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Drug: AKB-9778 Drug: Sham |
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Experimental: AKB-9778 15 mg BID + ranibizumab 0.3 mg
Subcutaneous AKB-9778 15 mg BID (total daily dose of 30 mg/day) plus ranibizumab 0.3 mg monthly intravitreal injection for 3 months.
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Drug: AKB-9778 Drug: ranibizumab Other Name: Lucentis |
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Active Comparator: ranibizumab 0.3 mg monotherapy
Placebo subcutaneous injection (BID) plus ranibizumab 0.3 mg monthly intravitreal injection for 3 months.
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Drug: ranibizumab
Other Name: Lucentis Drug: Placebo |
Primary Outcome Measures :
- Mean change from baseline in spectral domain optical coherence tomography (sdOCT)-measured central subfield thickness (CST) [ Time Frame: Month 3 ]
Secondary Outcome Measures :
- Mean change from baseline in Early Treatment Diabetic Retinopathy Study (ETDRS) Best Corrected Visual Acuity (BCVA) [ Time Frame: Month 3 ]
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| Ages Eligible for Study: | 18 Years to 80 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
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
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History of any of the following in the study eye (however, the following are not exclusionary in the fellow eye):
- Prior pars plana vitrectomy
- Any ocular surgery within 3 months prior to Day 1
- YAG capsulotomy within 3 months prior to Day 1
- 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
- Prior intravitreal, subtenon, or periocular steroid therapy within 3 months prior to Day 1
- Prior treatment with intravitreal anti-vascular endothelial growth factor (VEGF) treatment within 8 weeks prior to Day 1
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02050828
Locations
| United States, Arizona | |
| Pheonix, Arizona, United States, 85014 | |
| Pheonix, Arizona, United States, 85020 | |
| Tucson, Arizona, United States, 85704 | |
| United States, California | |
| Arcadia, California, United States, 91007 | |
| Bakersfield, California, United States, 93309 | |
| Beverly Hills, California, United States, 90211 | |
| Palm Desert, California, United States, 92260 | |
| Sacramento, California, United States, 95819 | |
| Santa Ana, California, United States, 92705 | |
| Santa Barbara, California, United States, 93103 | |
| United States, Colorado | |
| Golden, Colorado, United States, 80401 | |
| United States, Florida | |
| Boynton Beach, Florida, United States, 33426 | |
| Fort Lauderdale, Florida, United States, 33334 | |
| Fort Myers, Florida, United States, 33912 | |
| Miami, Florida, United States, 33126 | |
| Sarasota, Florida, United States, 34239 | |
| Stuart, Florida, United States, 34994 | |
| Winter Haven, Florida, United States, 33880 | |
| United States, Maryland | |
| Baltimore, Maryland, United States, 21287 | |
| United States, Michigan | |
| Jackson, Michigan, United States, 49202 | |
| United States, Nebraska | |
| Omaha, Nebraska, United States, 68198 | |
| United States, Nevada | |
| Reno, Nevada, United States, 89502 | |
| United States, New York | |
| Rochester, New York, United States, 14620 | |
| United States, North Carolina | |
| Charlotte, North Carolina, United States, 28210 | |
| United States, Ohio | |
| Cincinnati, Ohio, United States, 45242 | |
| Cleveland, Ohio, United States, 44195 | |
| United States, Oregon | |
| Portland, Oregon, United States, 97210 | |
| United States, South Carolina | |
| Florence, South Carolina, United States, 29501 | |
| United States, South Dakota | |
| Rapid City, South Dakota, United States, 57701 | |
| United States, Tennessee | |
| Nashville, Tennessee, United States, 37203 | |
| United States, Texas | |
| Abilene, Texas, United States, 79606 | |
| Austin, Texas, United States, 78705 | |
| Fort Worth, Texas, United States, 76102 | |
| Houston, Texas, United States, 77030 | |
| McAllen, Texas, United States, 78503 | |
| San Antonio, Texas, United States, 78240 | |
| United States, Utah | |
| Salt Lake City, Utah, United States, 84107 | |
| United States, Virginia | |
| Warrenton, Virginia, United States, 20186 | |
| United States, Washington | |
| Bellevue, Washington, United States, 98004 | |
Sponsors and Collaborators
Aerpio Therapeutics
| Responsible Party: | Aerpio Therapeutics |
| ClinicalTrials.gov Identifier: | NCT02050828 |
| Other Study ID Numbers: |
AKB-9778-CI-2003 |
| First Posted: | January 31, 2014 Key Record Dates |
| Last Update Posted: | March 16, 2017 |
| Last Verified: | March 2017 |
Additional relevant MeSH terms:
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Macular Edema Edema Macular Degeneration Retinal Degeneration Retinal Diseases Eye Diseases Ranibizumab |
Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Physiological Effects of Drugs Growth Inhibitors Antineoplastic Agents |