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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether adalimumab (Humira), administered as an injection during Boston Keratoprosthesis (KPro) eye surgery, is safe and well-tolerated. It targets individuals with severe eye conditions, such as significant corneal vision impairment or scarring, who plan to undergo KPro surgery. Participants should have vision worse than 20/200 in one eye and worse than 20/40 in the other, with a poor prognosis for traditional corneal transplants. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this treatment.

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.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

Research has shown that adalimumab, also known as Humira, is generally safe for treating eye inflammation. Studies have found that when used for noninfectious uveitis, patients experienced fewer flare-ups and vision issues. However, some reported more side effects compared to those not receiving the treatment.

Another study found that adalimumab has a manageable side effect profile, indicating that most people tolerate it well. Although some patients may experience a return of symptoms, the treatment is overall considered effective and safe.

In this trial, researchers are testing adalimumab to assess patient tolerance during a specific eye surgery. Since it is already used for other eye conditions, strong evidence supports its safety. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Most treatments for eye inflammation focus on reducing symptoms with steroids or non-steroidal anti-inflammatory drugs. However, Adalimumab (Humira) is unique because it targets tumor necrosis factor-alpha (TNF-alpha), a specific protein in the body that plays a key role in inflammation. By directly inhibiting TNF-alpha, Adalimumab offers a more targeted approach, potentially reducing inflammation more effectively and with fewer side effects than traditional therapies. Researchers are excited about this treatment because it promises to provide relief for patients who do not respond well to existing options.

What evidence suggests that Humira might be an effective treatment for eye inflammation?

Studies have shown that adalimumab, also known as Humira, effectively reduces eye inflammation, particularly in conditions like non-infectious uveitis. Research indicates that patients using Humira for eye inflammation experienced success rates between 56% and 66%. It improves vision and reduces the need for other strong medications. Humira is already approved for treating various types of uveitis, which involves inflammation inside the eye. This trial will evaluate its potential benefits for eye inflammation during surgeries such as the Boston Keratoprosthesis (KPro). ^{3 6 7 8 9}

Who Is on the Research Team?

Thomas Dohlman, MD

Principal Investigator

Massachusetts Eye and Ear

Are You a Good Fit for This Trial?

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. oftalmoloji.org oftalmoloji.org/articles/adalimumab-in-focus-evaluating-effectiveness-and-safety-in-non-infectious-uveitis-at-a-tertiary-referral-center-in-turkiye/tjo.galenos.2025.67513

Adalimumab in Focus: Evaluating Effectiveness and Safety ... The study assessed the impact of ADA treatment on best corrected visual acuity (BCVA), number of immunosuppressive therapies (IST), ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12540958/

Adalimumab in non-infectious uveitis, towards a real-world ... The low prevalence of NIU limits real-world studies and few retrospective works have shown ADA's effectiveness in reducing ocular inflammation [ ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S0161642025006062

Evaluating the Effectiveness of Escalating to Weekly ... Previous studies of weekly ADA dosing for ocular inflammation reported success rates of 56%-66%, which is of a similar range to our study's ...

4. nejm.org nejm.org/doi/full/10.1056/NEJMoa1509852

Adalimumab in Patients with Active Noninfectious Uveitis We conducted a trial to assess the efficacy and safety of adalimumab as a glucocorticoid-sparing agent for the treatment of noninfectious uveitis.

5. humira.com humira.com/uveitis

HUMIRA® (adalimumab) for Uveitis (UV) HUMIRA is a prescription medicine used to treat non-infectious intermediate (middle part of the eye), posterior (back of the eye), and panuveitis (all parts ...

6. thelancet.com thelancet.com/journals/lancet/article/PIIS0140-6736(24)02468-1/fulltext

Stopping of adalimumab in juvenile idiopathic arthritis ... Our study showed that recurrence rates of inflammation were significantly higher in patients who stopped adalimumab compared with those who ...

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40511491/

Long-Term Effectiveness and Safety of Weekly ... Weekly adalimumab treatment is a viable option for managing inflammation in refractory uveitis, providing enhanced efficacy to the standard dose.

8. sciencedirect.com sciencedirect.com/science/article/pii/S0002939422001088

Long-Term Follow-up of Patients With Uveitis Treated ... Adalimumab is effective for patients with noninfectious uveitis, with an acceptable side effect profile. Although relapses can occur, the majority of the ...

9. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8477319/

Adalimumab in patients with vision-threatening uveitis Of the 89 involved eyes, 21 (23.6%) eyes improved by at least 2 lines, 5 eyes (5.6%) worsened by at least 2 lines while the rest, 63 (70.8%) eyes had similar ...