Trials / Not Yet Recruiting
Not Yet RecruitingNCT07429474
Safety and Immunogenicity of PRO-169 in Patients With Diabetic Macular Edema
Phase I Clinical Trial to Evaluate Safety by Determining Immunogenicity Following Unilateral Intravitreal Administration of PRO-169 in Patients With Diabetic Macular Edema
- Status
- Not Yet Recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- Sponsor
- Laboratorios Sophia S.A de C.V. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
Phase I, prospective, interventional, open-label, multicenter clinical trial to evaluate the safety of intravitreal PRO-169 through the presence of serum anti-drug antibodies (ADAs) to bevacizumab.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | PRO-169 | Bevacizumab 1.25 mg / 0.05mL for intravitreal injection. |
Timeline
- Start date
- 2026-03-01
- Primary completion
- 2026-12-15
- Completion
- 2026-12-15
- First posted
- 2026-02-24
- Last updated
- 2026-03-13
Locations
1 site across 1 country: Mexico
Source: ClinicalTrials.gov record NCT07429474. Inclusion in this directory is not an endorsement.