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

Trial Summary

What is the purpose of this trial?

This study will investigate the efficacy and safety of OZURDEX® (dexamethasone intravitreal implants; DEX, Allergan, Inc. Irvine, CA) as monotherapy for the treatment of non-infectious intermediate-, posterior- or panuveitis. This is a prospective randomized controlled clinical trial taking place at the University of Ottawa Eye Institute, Ottawa, Ontario, Canada, and other possible centers in Canada. Consecutive consenting subjects who meet inclusion/exclusion criteria will be selected to participate in this study. The subjects must have either non-infectious intermediate, posterior, or panuveitis. The subjects will be randomly chosen to be part of one of two groups; one group will receive DEX as monotherapy and the other group will receive oral prednisone. Approximately 84 eyes (42 per arm) will take part in study. The primary outcome will measure the proportion of eyes with a vitreous haze score of 0 six months post initial treatment. Secondary measures will include best corrected visual acuity (BCVA), central retinal thickness (CRT) measured by spectral-domain optical coherence tomography (SD-OCT), time to vitreous haze resolution and time to failure defined at number of months with DEX implant until an adjunct therapy is indicated. Baseline measurements will be recorded within 1 month prior to treatment in both groups, with follow up measurements collected at 0, 1, 2, 4, 6 and 12 months post-operatively.

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 data supports the effectiveness of the Ozurdex implant for treating uveitis?

Research shows that the Ozurdex implant, which releases the drug dexamethasone, is effective in controlling inflammation in uveitis, including in children and after cataract surgery. It has been shown to provide long-term disease control with repeated use. ^{1 2 3 4 5}

Is the Ozurdex implant safe for treating uveitis?

The Ozurdex implant, which contains dexamethasone, is generally considered safe for treating uveitis, with studies showing it can effectively manage inflammation and reduce the need for other medications. However, some rare side effects, like implant fracture, have been reported. ^{1 5 6 7 8}

How is the Ozurdex drug unique for treating uveitis?

Ozurdex is a unique treatment for uveitis because it is a biodegradable implant that delivers dexamethasone directly into the eye, providing a sustained release of medication over time. This method can offer long-term control of inflammation with fewer systemic side effects compared to oral or injected steroids. ^{2 3 4 5 9}

Eligibility Criteria

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.

I am 18 years old or older.

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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]

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]

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]

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]

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]

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]

References

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

The dexamethasone drug delivery system: indications and evidence. [2022]

2. China pubmed.ncbi.nlm.nih.gov

Utilizing dexamethasone intravitreal implant to control postoperative inflammation in refractory uveitis undergoing cataract surgery. [2021]

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

Treatment with repeat dexamethasone implants results in long-term disease control in eyes with noninfectious uveitis. [2022]

4. India pubmed.ncbi.nlm.nih.gov

Efficacy of Ozurdex implant in treatment of noninfectious intermediate uveitis. [2018]

5. Germany pubmed.ncbi.nlm.nih.gov

Dexamethasone intravitreal implant (Ozurdex®) for pediatric uveitis. [2022]

6. India pubmed.ncbi.nlm.nih.gov

Fractured dexamethasone implant (OZURDEX®) following intravitreal injection. [2021]

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

Dexamethasone intravitreal implant for treatment of uveitic persistent cystoid macular edema in vitrectomized patients. [2022]

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

Intravitreal dexamethasone implants facilitate the management of refractory Behçet's uveitis with vasculitis. [2023]

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

Incomplete scleral penetration of dexamethasone (Ozurdex) intravitreal implant. [2020]