Humira for Eye Inflammation

Overseen By Michael Cheung, MSc, CCRP

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Massachusetts Eye and Ear Infirmary

Disqualifiers: Tuberculosis, Hepatitis B/C, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: 1 day

8 Participants Needed

Trial Summary

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.

What data supports the effectiveness of the drug Humira (Adalimumab) for treating eye inflammation?

Research shows that Humira (Adalimumab) is effective in reducing inflammation in non-infectious uveitis (eye inflammation) by lowering the risk of treatment failure and improving visual outcomes compared to a placebo. It is generally well tolerated and has a low incidence of antibodies against the drug. ^{1 2 3 4 5}

Is Humira (Adalimumab) generally safe for humans?

Research on Humira (Adalimumab) for non-infectious uveitis, a type of eye inflammation, has shown it to be generally safe for humans. Studies have focused on its safety and effectiveness, and while some research involved animal testing, the global trials in humans reported safety outcomes. ^{4 6 7 8 9}

How is the drug Humira unique for treating eye inflammation?

Humira (adalimumab) is unique because it is the first biological agent approved specifically for non-infectious intermediate, posterior, and panuveitis, reducing the risk of treatment failure compared to placebo. It works by inhibiting tumor necrosis factor (TNF)-α, a substance in the body that causes inflammation, and is administered as a subcutaneous injection. ^{3 10 11 12 13}

What is the purpose of this trial?

This trial is studying the safety and tolerability of receiving an injection of adalimumab (Humira) during the Boston Keratoprosthesis (KPro) surgery.

Research Team

Thomas Dohlman, MD

Principal Investigator

Massachusetts Eye and Ear

Eligibility Criteria

This trial is for individuals undergoing Boston Keratoprosthesis surgery due to severe eye conditions like Bullous Pemphigoid or Stevens-Johnson Syndrome. Specific eligibility criteria are not provided, but typically participants must meet certain health standards and not have conditions that could interfere with the study.

Inclusion Criteria

I am a candidate for artificial cornea surgery according to my doctor's assessment.

My eyes have severe scarring or blood vessel growth, making cornea transplant unlikely to succeed.

Patients with intact nasal light projection

Exclusion Criteria

Participation in another interventional study at the time of screening

Inability to wear contact lens

Pregnancy (positive pregnancy test) or lactating

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a subconjunctival injection of adalimumab during the Boston Keratoprosthesis surgery

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment through eye examinations and photos

4 weeks

Every 2 weeks (in-person)

Treatment Details

Interventions

• Adalimumab

Trial Overview The trial is examining the safety of administering an adalimumab injection (Humira) during KPro surgery. Adalimumab is used to reduce inflammation, which can be a complication after this type of eye surgery.

Participant Groups

Group I: Adalimumab (Humira) Experimental Treatment 1 Intervention

This arm will receive the study intervention.

Who Is Running the Clinical Trial?

Massachusetts Eye and Ear Infirmary

Lead Sponsor

Trials

115

Recruited

15,000+

References

1. England pubmed.ncbi.nlm.nih.gov

Adalimumab for Ocular Inflammation. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Serum cytokine profile in adalimumab-treated refractory uveitis patients: decreased IL-22 correlates with clinical responses. [2023]

3. New Zealand pubmed.ncbi.nlm.nih.gov

Adalimumab: A Review in Non-Infectious Non-Anterior Uveitis. [2017]

4. Germany pubmed.ncbi.nlm.nih.gov

Evaluation of potential retinal toxicity of adalimumab (Humira). [2021]

5. England pubmed.ncbi.nlm.nih.gov

Efficacy, retention rate and safety of adalimumab treatment in patients with non-infectious uveitis and scleritis: a real-world, retrospective, single-centre study. [2023]

6. England pubmed.ncbi.nlm.nih.gov

Adalimumab in Active and Inactive, Non-Infectious Uveitis: Global Results from the VISUAL I and VISUAL II Trials. [2019]

7. Germany pubmed.ncbi.nlm.nih.gov

Ocular toxicity of intravitreous adalimumab (Humira) in the rabbit. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

Toxicity of high-dose intravitreal adalimumab (Humira) in the rabbit. [2022]

9. England pubmed.ncbi.nlm.nih.gov

Efficacy and Safety of Adalimumab Therapy for the Treatment of Non-infectious Uveitis: Efficacy comparison among Uveitis Aetiologies. [2022]

10. Italy pubmed.ncbi.nlm.nih.gov

Long-term control of non-infectious paediatric panuveitis refractory to traditional immunesuppressive therapy, successfully treated with Adalimumab (HumiraTM). [2017]

11. England pubmed.ncbi.nlm.nih.gov

Adalimumab in the therapy of uveitis in childhood. [2022]

12. England pubmed.ncbi.nlm.nih.gov

Adalimumab in combination with methotrexate for refractory uveitis associated with juvenile idiopathic arthritis: a RCT. [2021]

13. United States pubmed.ncbi.nlm.nih.gov

Ocular toxoplasmosis following anti-tumour necrosis factor-α therapy combined with oral methotrexate therapy: A case report and review of literature. [2023]