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Monoclonal Antibodies
AXT107 0.1 mg for Diabetic Macular Edema (CONGO Trial)
Phase 1 & 2
Waitlist Available
Research Sponsored by AsclepiX Therapeutics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 0 to week 48
Awards & highlights
CONGO Trial Summary
This trial is testing a new drug for treating diabetic macular edema. The safety and effectiveness of the drug will be assessed over 48 weeks in up to 18 patients.
Eligible Conditions
- Diabetic Macular Edema
CONGO Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ day 0 to week 48
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 0 to week 48
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Safety as Assessed by Incidence of Adverse Events (AEs)
Secondary outcome measures
Efficacy as Assessed by Central Retinal Thickness (CST)
Diabetic Retinopathy
CONGO Trial Design
3Treatment groups
Experimental Treatment
Group I: Mid DoseExperimental Treatment1 Intervention
AXT107 0.25 mg/eye
Group II: Low DoseExperimental Treatment1 Intervention
AXT107 0.1 mg/eye
Group III: High DoseExperimental Treatment1 Intervention
AXT107 0.5 mg/eye
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Who is running the clinical trial?
AsclepiX Therapeutics, Inc.Lead Sponsor
2 Previous Clinical Trials
18 Total Patients Enrolled
Amir Shojaei, PhDStudy DirectorAsclepix Therapeutics
1 Previous Clinical Trials
3 Total Patients Enrolled
Frequently Asked Questions
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