Safety and Pilot Efficacy of AKB-9778 in Subjects With Diabetic Macular Edema

ClinicalTrials.gov ID: NCT01702441

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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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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 identification

NCT ID: NCT01702441
Recruitment status: Completed
Study type: Interventional
Phase: Phase 1, Phase 2
Lead sponsor: Aerpio Therapeutics; Industry
Enrollment: 24 participants

Conditions and interventions

Conditions

Diabetic Macular Edema (DME)

Interventions

Subcutaneous AKB-9778 Drug

Drug

Eligibility (public fields only)

Age range: 18 Years to 80 Years
Sex: All
Healthy volunteers: Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Sep 2012 (Type not available)
Primary completion: Sep 2013 (Actual)
Completion: Dec 2014 (Actual)
Last update posted: Mar 27, 2015

2012 – 2014

United States locations

U.S. sites: 6
U.S. states: 6
U.S. cities: 6

Facility	City	State	ZIP	Site status
Not listed	Beverly Hills	California	—	—
Not listed	Winter Haven	Florida	—	—
Not listed	Baltimore	Maryland	—	—
Not listed	Boston	Massachusetts	—	—
Not listed	Charlotte	North Carolina	—	—
Not listed	Cincinnati	Ohio	—	—

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT01702441, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Mar 27, 2015 · Synced Nov 14, 2026