Trials / Not Yet Recruiting
Not Yet RecruitingNCT06926478
Subconjunctival Humira for Boston Keratoprosthesis
Clinical Trial to Evaluate Short-term Safety of Subconjunctival Adalimumab in Combination With Type 1 Boston Keratoprosthesis Implantation
- Status
- Not Yet Recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 8 (estimated)
- Sponsor
- Massachusetts Eye and Ear Infirmary · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This trial is studying the safety and tolerability of receiving an injection of adalimumab (Humira) during the Boston Keratoprosthesis (KPro) surgery.
Detailed description
This is a Phase I, Open-label, IND trial for participants undergoing a Boston Keratoprosthesis (KPro) procedure, to receive an injection of adalimumab (Humira), to study the safety and tolerability as well, to study whether there is a decrease to post surgical complications, and symptoms that participants would experience, if they did not receive the injection. The study will recruit eight (8) participants, who will be monitored for thirty (30) days after the surgery, through eye examination and eye photos.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Adalimumab Injection | 10% (4.0mg/0.04ml) dissolved in sterile saline to be injected once during the time of the Boston Keratoprosthesis (Kpro) Surgery. |
Timeline
- Start date
- 2026-06-01
- Primary completion
- 2027-06-01
- Completion
- 2028-06-01
- First posted
- 2025-04-13
- Last updated
- 2026-03-27
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT06926478. Inclusion in this directory is not an endorsement.