Ozurdex Implant for Uveitis

(OM Trial)

Overseen By Miriam Muir, RN

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Ottawa Hospital Research Institute

Must not be taking: Systemic steroids, Immunomodulatory therapy

Disqualifiers: Anterior uveitis, Macular edema, Glaucoma, others

Stay on Your Current Meds You can continue your current medications while participating

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

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 13

Duration: 6 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines the effectiveness and safety of an eye implant that slowly releases dexamethasone, a type of steroid, for treating non-infectious uveitis (eye inflammation) in the middle or back of the eye. Participants will either receive the implant or take oral prednisone, another steroid, to determine which better reduces eye inflammation over time. Suitable candidates have active uveitis, with symptoms such as inflammation or a cloudy view (vitreous haze) in the affected eye. As a Phase 4 trial, this research aims to understand how this already FDA-approved and effective treatment can benefit more patients.

Will I have to stop taking my current medications?

The trial requires that you stop taking certain medications, such as topical corticosteroids, non-steroidal anti-inflammatory drugs, systemic steroids, or immunomodulatory therapy, at least one month before screening.

What is the safety track record for these treatments?

Research has shown that the intravitreal dexamethasone (DEX) implant, known as OZURDEX®, has been well-tolerated in past studies. These studies indicate that the implant effectively controls eye inflammation, improves vision, and reduces macular thickness, which is important for eye health.

One large study found that OZURDEX® significantly improved vision for patients over three years. Although reports of eye-related side effects have increased, this results from better tracking rather than new safety issues.

Since this treatment is being studied in a Phase 4 trial, it is already approved for certain conditions, indicating a strong safety record. This approval means it has been widely used, and its safety in humans is well-documented. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Unlike the standard of care for uveitis, which often involves oral steroids like prednisone, the Ozurdex implant offers a unique approach by delivering dexamethasone directly into the eye via an intravitreal implant. This targeted delivery method allows for a sustained release of medication, potentially reducing systemic side effects commonly associated with oral steroids. Researchers are excited about the Ozurdex implant because it could offer a more focused treatment with potentially fewer side effects, providing a more comfortable experience for patients and possibly leading to quicker relief from inflammation.

What evidence suggests that this trial's treatments could be effective for uveitis?

Research shows that the dexamethasone (DEX) implant, placed directly in the eye, effectively treats uveitis, a type of eye inflammation. Studies have found that it controls inflammation, improves vision, and reduces eye swelling. Participants in this trial may receive the DEX implant as part of the experimental group. One study confirmed that a single dose of the DEX implant improved vision and reduced swelling in people with uveitis. Over the past ten years, this treatment has consistently reduced eye inflammation and improved eyesight for many patients. The DEX implant has also shown positive results for other similar eye conditions, supporting its potential effectiveness for uveitis. ^{1 3 6 7 8}

Are You a Good Fit for This Trial?

Adults diagnosed with non-infectious intermediate, posterior, or panuveitis can join this trial. They must have active uveitic disease but no diabetes-related macular edema, ocular infections, or recent eye surgeries. Participants shouldn't have used corticosteroids or immunomodulatory therapies within the last month and not be pregnant.

Inclusion Criteria

I have active inflammation in my eye shown by retinal lesions or vitreous haze.

I have a type of eye inflammation not caused by an infection.

Exclusion Criteria

I have not had eye injections in the last 6 months.

I have swelling in the back of my eye due to diabetes or another eye condition.

I have a history of glaucoma.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either a 0.7mg intravitreal dexamethasone implant or oral prednisone with tapering

6 months

Visits at baseline, 1, 2, 4, 6 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

Visits at 12 months

What Are the Treatments Tested in This Trial?

Interventions

• Dexamethasone
• Prednisone

Trial Overview The study compares Ozurdex (dexamethasone) implants as a single treatment against oral prednisone for uveitis. Conducted in Canada, it randomly assigns participants to either treatment and follows them for up to a year to see how well each therapy clears inflammation and improves vision.

How Is the Trial Designed?

Group I: Intravitreal Dexamethasone Implant Group Experimental Treatment 1 Intervention

Subjects randomized to the experimental group will receive a 0.7mg intravitreal dexamethasone (DEX) implant which will be injected in the vitreous cavity as one of the treatments of interest in this study.

Group II: Prednisone Taper Group Active Control 1 Intervention

Subjects randomized to the comparator group will receive oral prednisone. The initial dose is expected to range between 40 to 60mg of oral prednisone per day, with gradual tapering to the lowest dose that controls inflammation and eventually transitioning to a maintenance dose. Maintenance dose will be gradually lowered as per standard of care if remission is achieved for 6 to 12 months.

Dexamethasone is already approved in European Union, United States, Canada, Japan for the following indications:

Approved in European Union as Dexamethasone for:

• Inflammation
• Allergic reactions
• Respiratory diseases
• Skin conditions
• Eye diseases
• Immune system disorders

Approved in United States as Dexamethasone for:

• Inflammatory conditions
• Allergic states
• Respiratory diseases
• Blood disorders
• Neoplastic diseases
• Nervous system disorders

Approved in Canada as Dexamethasone for:

• Inflammation
• Allergic reactions
• Respiratory diseases
• Skin conditions
• Eye diseases

Approved in Japan as Dexamethasone for:

• Inflammatory conditions
• Allergic states
• Respiratory diseases
• Blood disorders

Who Is Running the Clinical Trial?

Ottawa Hospital Research Institute

Lead Sponsor

Trials

585

Recruited

3,283,000+

Published Research Related to This Trial

In a study of 13 patients with uveitic macular edema, treatment with a 0.7 mg dexamethasone intravitreal implant led to a significant reduction in central retinal thickness and improved visual acuity, with 52.9% of eyes gaining 2 lines or more after 3 months.

The treatment was generally safe, with common side effects including ocular hypertension in 47.1% of cases, but overall, the visual outcomes were favorable and the safety profile was considered acceptable.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dexamethasone intravitreal implant for treatment of uveitic persistent cystoid macular edema in vitrectomized patients. Adán, A., Pelegrín, L., Rey, A., et al.[2022]

The Ozurdex dexamethasone drug delivery system (DDS) is an effective biodegradable implant for treating macular edema associated with retinal vein occlusion and other conditions, providing sustained release of dexamethasone directly to the eye.

While the dexamethasone DDS shows a favorable safety profile, potential side effects include temporary cataract formation and elevated intraocular pressure, which can typically be managed with medication.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The dexamethasone drug delivery system: indications and evidence. London, NJ., Chiang, A., Haller, JA.[2022]

In a study of 61 patients with refractory Behçet's uveitis, the dexamethasone implant Ozurdex® significantly improved fluorescein angiography and vitritis scores compared to those not receiving the implant after more than 12 months of treatment.

Ozurdex® was found to be effective and safe, as it helped control inflammation, reduced the need for daily glucocorticoids, and decreased relapse rates, despite a slight increase in posterior capsule opacification.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intravitreal dexamethasone implants facilitate the management of refractory Behçet's uveitis with vasculitis. Tao, T., Yang, S., He, D., et al.[2023]

In a study of 10 eyes from 7 patients with refractory uveitis, the intravitreal dexamethasone implant (Ozurdex) significantly improved best-corrected visual acuity (BCVA) at 1, 3, and 6 months post-operation, indicating its effectiveness in managing inflammation after cataract surgery.

Ozurdex was found to be safe, with no significant changes in intraocular pressure (IOP) for most patients, and it allowed for a reduction in systemic steroid use in 71.4% of cases, demonstrating its potential to control postoperative inflammation effectively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Utilizing dexamethasone intravitreal implant to control postoperative inflammation in refractory uveitis undergoing cataract surgery. Li, YT., Cui, XX., Yang, XT., et al.[2021]

In a study of 38 eyes from 27 patients with uveitis treated with dexamethasone implants, significant improvements in best-corrected visual acuity (BCVA) and central retinal thickness (CRT) were observed, indicating effective long-term management of ocular inflammation.

The treatment was generally safe, with minimal ocular complications; only 7 instances of increased intraocular pressure were noted, all manageable with medication, and no surgeries were required for complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment with repeat dexamethasone implants results in long-term disease control in eyes with noninfectious uveitis. Tomkins-Netzer, O., Taylor, SR., Bar, A., et al.[2022]

Ozurdex, a biodegradable intravitreal implant containing dexamethasone, is approved in the UK for treating macular edema due to retinal vein occlusion, diabetic maculopathy, and non-infectious uveitis.

A case report highlighted a rare incident where the implant was incompletely injected into the eye, but it was managed conservatively with a positive outcome, suggesting that while complications can occur, they may not always lead to severe consequences.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Incomplete scleral penetration of dexamethasone (Ozurdex) intravitreal implant. Sherman, T., Raman, V.[2020]

In a study of 10 children with uveitis, the intravitreal dexamethasone implant (Ozurdex) showed significant effectiveness, with 86% of eyes experiencing improved visual acuity and 93% showing reduced intraocular inflammation within 3 months after treatment.

While the treatment was generally safe, some complications were noted, including cataract progression and elevated intraocular pressure, indicating the need for careful monitoring, especially in pediatric patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dexamethasone intravitreal implant (Ozurdex®) for pediatric uveitis. Sella, R., Oray, M., Friling, R., et al.[2022]

In a retrospective study of 15 patients with noninfectious intermediate uveitis, the Ozurdex implant significantly improved visual acuity and reduced central retinal thickness after 6 weeks, indicating its efficacy in managing this condition.

While the Ozurdex implant effectively controlled ocular inflammation and cystoid macular edema, some patients experienced complications such as cataracts and increased intraocular pressure, highlighting the need for monitoring.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of Ozurdex implant in treatment of noninfectious intermediate uveitis. Palla, S., Biswas, J., Nagesha, CK.[2018]

Dexamethasone implant (Ozurdex™) is generally considered a safe treatment with minimal adverse events, highlighting its favorable safety profile.

The study presents a rare case of a fractured Ozurdex™ implant occurring immediately after injection, providing insights into potential complications and their outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fractured dexamethasone implant (OZURDEX®) following intravitreal injection. Aljohani, SM., Al-Shehri, AM., Al-Rubaie, KR.[2021]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4539658/

Results of intravitreal dexamethasone implant 0.7 mg ... Results showed clear benefits of intravitreal dexamethasone in controlling the inflammation, improving the vision and decreasing macular thickness.

2. hcp.ozurdex.com hcp.ozurdex.com/clinical-efficacy

OZURDEX® Clinical Efficacy in DME Only 14% of the study patients completed the month 39 visit (16.8% from OZURDEX® and 12.2% from sham).

3. sciencedirect.com sciencedirect.com/science/article/pii/S2319417023000446

Real-world effectiveness of intravitreal dexamethasone ... This cohort study found 39.8% and 55.1% of IDI-treated eyes with DME and CRVO ineligible for inclusion in pRCTs, respectively.

4. europeanreview.org europeanreview.org/article/31535

A review of ten years of experience using dexamethasone ... DEX-I is effective in reducing edema, improving inflammation and improving vision when treating various conditions of uveitis.

5. frontiersin.org frontiersin.org/journals/medicine/articles/10.3389/fmed.2023.1126724/full

Efficacy and safety of single-dose intravitreal ... This meta-analysis confirmed favorable visual prognosis and anatomical improvement in patients with UME, after receiving the single-dose DEX implant.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9437191/

Real-Life Efficacy, Safety, and Use of Dexamethasone ... LOUVRE 2 confirms DEX efficacy on visual acuity and CRT in predominantly DEX-pretreated patients with relatively old/stabilized uveitis.

7. bmcpharmacoltoxicol.biomedcentral.com bmcpharmacoltoxicol.biomedcentral.com/articles/10.1186/s40360-025-00866-7

Assessment the real-world safety of intravitreal ... A substantial upward trend in AE reports was observed, indicating increasing pharmacovigilance data. The Eye disorders was identified as the ...

8. aetna.com aetna.com/cpb/medical/data/700_799/0795.html

Dexamethasone Ophthalmic Implant (Ozurdex) and Insert ... The authors concluded that intravitreal DEX injection was useful for suppressing intra-ocular inflammation, provided good visual and anatomical results in the ...