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Corticosteroid
Ozurdex Implant for Uveitis (OM Trial)
Phase 4
Recruiting
Research Sponsored by Ottawa Hospital Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Active uveitic disease at Screening/Baseline defined by the presence of at least 1 of the following parameters: 1) Active, inflammatory, chorioretinal and/or inflammatory retinal vascular lesion 2) ≥ 1+ vitreous haze (NEI/SUN criteria)
Diagnosis of non-infectious intermediate, posterior, or panuveitis in at least one eye
Timeline
Screening 3 weeks
Treatment Varies
Follow Up measurements obtained at: 1 month, 2 months, 4 months, 6 months, 12 months
Awards & highlights
OM Trial Summary
This triallooks at whether a drug (DEX) can treat non-infectious eye diseases (intermediate-, posterior- or panuveitis). Subjects will be randomly assigned to receive DEX or oral prednisone to measure outcomes.
Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Ozurdex may cause increased eye pressure, cataract formation, eye infection risk increase, and possible visual disturbances. Prednisone can lead to mood swings, weight gain, high blood sugar levels among other systemic effects.
OM Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have active inflammation in my eye shown by retinal lesions or vitreous haze.
Select...
I have a type of eye inflammation not caused by an infection.
Select...
I am 18 years old or older.
OM Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ measurements obtained at: 1 month, 2 months, 4 months, 6 months, 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~measurements obtained at: 1 month, 2 months, 4 months, 6 months, 12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Percentage of patients with Vitreous Haze score of 0 at 6 months
Secondary outcome measures
Anterior chamber cells/flare from baseline to various time points
Best Corrected Visual Acuity at various time points
Change in National Eye Institute Visual Function Questionnaire 25 Score
+6 moreSide effects data
From 2022 Phase 2 trial • 46 Patients • NCT0300352060%
Fatigue
53%
Peripheral sensory neuropathy
49%
Neutropenia
42%
Nausea
30%
Diarrhoea
28%
Decreased appetite
26%
Headache
26%
Insomnia
23%
Vomiting
23%
Dyspnoea
23%
Alopecia
21%
Constipation
21%
Pyrexia
21%
Dizziness
21%
Cough
19%
Dry mouth
19%
Hypokalaemia
19%
Rash
19%
Stomatitis
16%
Back pain
16%
Myalgia
16%
Anaemia
16%
Leukopenia
16%
Weight decreased
14%
Oropharyngeal pain
14%
Febrile neutropenia
14%
Oedema peripheral
14%
Dysgeusia
12%
Oral candidiasis
12%
Abdominal pain upper
12%
Pruritus
12%
Infusion related reaction
9%
Mucosal inflammation
9%
Lung infection
9%
Arthralgia
9%
Vision blurred
9%
Abdominal pain
9%
Pain in extremity
9%
Muscle spasms
9%
Thrombocytopenia
9%
Taste disorder
9%
Chills
9%
Urinary tract infection
9%
Fall
7%
Hypomagnesaemia
7%
Hot flush
7%
Influenza
7%
Nasopharyngitis
7%
Depression
7%
Hypotension
7%
Upper respiratory tract infection
7%
Dry skin
5%
General physical health deterioration
5%
Infection
5%
Oral herpes
5%
Dysuria
5%
Atrial fibrillation
5%
Pneumonia
5%
Restless legs syndrome
2%
Device related infection
2%
Tumour pain
2%
Autoimmune hepatitis
2%
Seborrhoeic dermatitis
2%
Pancytopenia
2%
Haemophagocytic lymphohistiocytosis
2%
Cerebrovascular accident
2%
Lymphoma
2%
Myocardial ischaemia
2%
Acute kidney injury
2%
Spinal pain
2%
Cardiac arrest
2%
Perirectal abscess
2%
Meningitis bacterial
2%
Staphylococcal bacteraemia
2%
Viral diarrhoea
2%
Hyponatraemia
2%
Deep vein thrombosis
2%
Venous thrombosis
2%
Gastrooesophageal reflux disease
2%
Histiocytosis haematophagic
2%
Clear cell renal cell carcinoma
2%
Diffuse large B-cell lymphoma recurrent
2%
Pulmonary embolism
2%
Erythema
100%
80%
60%
40%
20%
0%
Study treatment Arm
DUR + R-CHOP
DUR + R2-CHOP
OM Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Intravitreal Dexamethasone Implant GroupExperimental Treatment1 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 GroupActive Control1 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.
Find a Location
Who is running the clinical trial?
Ottawa Hospital Research InstituteLead Sponsor
561 Previous Clinical Trials
2,785,410 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility 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.I have used a corticosteroid cream within the last month.I have active inflammation in my eye shown by retinal lesions or vitreous haze.I have an active eye disease or infection.I have not had eye surgery in the last 6 months.I have a type of eye inflammation not caused by an infection.I am 18 years old or older.I have inflammation in the front part of my eye.I haven't taken NSAIDs, steroids, or immune therapies like methotrexate in the last month.I am not pregnant, breastfeeding, nor planning to become pregnant during the study.My eye pressure is over 21 mmHg or I have normal-tension glaucoma.
Research Study Groups:
This trial has the following groups:- Group 1: Intravitreal Dexamethasone Implant Group
- Group 2: Prednisone Taper Group
Awards:
This trial has 3 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has the Intravitreal Dexamethasone Implant Group received official sanction from the FDA?
"With a score of 3, Intravitreal Dexamethasone Implant Group is considered to be safe as it has been approved for use in Phase 4 trials."
Answered by AI
What is the maximum number of participants being accepted for this clinical trial?
"Affirmative. The information on clinicaltrials.gov indicates that this medical trial is actively enrolling patients and has been since November 2021. 84 individuals from a single site are needed for the study's completion, with the most recent update occurring in December 2022."
Answered by AI
What conditions is Intravitreal Dexamethasone Implant Group typically employed to treat?
"Intravitreal Dexamethasone Implant Group is normally deployed to treat ocular disorders like sympathetic ophthalmia and branch retinal vein occlusion. It has also been utilized successfully in the management of macular edema, as well as a variety of infectious diseases."
Answered by AI
Have any previous research projects looked into the Intravitreal Dexamethasone Implant Group?
"Presently, 836 clinical trials related to the Intravitreal Dexamethasone Implant Group are in progress. Out of those, 215 have reached Phase 3 development. Most studies for this drug treatment are based in Waterloo, Iowa; however there are 31257 locations across the world actively running research on it."
Answered by AI
Are there still opportunities for individuals to take part in this experiment?
"That is correct. According to information hosted on clinicaltrials.gov, this medical experiment was originally posted on November 30th 2021 and has since been recruiting patients actively. The researchers are seeking 84 candidates at 1 site."
Answered by AI
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