A Phase 3 interventional study of IRX-101 and Control in Diabetic Macular Edema, Branch Retinal Vein Occlusion and Glaucoma/Closed Angle Glaucoma, sponsored by iRenix Medical, Inc.. Terminated at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-05-24.
Sponsored by iRenix Medical, Inc. · Phase 3, Interventional, and Treatment
This is a randomized, double-masked, multicenter, study to evaluate the efficacy, safety, and tolerability of IRX-101 versus 5% povidone-iodine (PI) in subjects receiving intravitreal anti-VEGF injections. The study will be conducted in up to 30 centers in the United States (US).
Intravitreal injection therapy (IVT) of anti-vascular endothelial growth factor (VEGF) agents has transformed the treatment landscape of several retinal diseases, including exudative (wet) macular degeneration, retinal vein occlusion, diabetic macular edema, and choroidal neovascularization. The most common adverse effects of IVT occur due to the side effects of Povidone-Iodine 5% (PI; brand name: Betadine® 5%; Alcon, Fort Worth, TX), the antiseptic placed on the ocular surface prior to each injection. PI is nearly universally used to prevent ocular infection (endophthalmitis). PI leads to marked corneal epithelial toxicity in humans,6, 7 resulting in debilitating side effects including decreased visual acuity and pain that can last more than 3 days post-IVT. Post-IVT pain is severe enough to require oral analgesics in up to 30% of patients and is a frequent cause of treatment discontinuation. Therefore, there is an unmet need in ophthalmology for a potent ocular antiseptic with a superior safety profile.
289 studies on the registry are indexed under Retinal Vein Occlusion; 32 are open to participants now.
This study's enrollment of 5 is below the median of 51 across 208 interventional studies indexed under Retinal Vein Occlusion.
Browse Retinal Vein Occlusion studies →iRenix Medical, Inc. is the lead sponsor of 3 studies on the registry; 1 is open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
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Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
IRX-101 drops instilled prior to intravitreal injection
Drug: IRX-101
Povidone-Iodine/Betadine drops instilled prior to intravitreal injection
Drug: Control
IRX-101 to prevent infectious endophthalmitis following intravitreal injection therapy (IVT)
Also known as: Test Arm 1
Providone-Iodine Betadine to prevent infectious endophthalmitis following intravitreal injection therapy (IVT)
Incidence of infectious endophthalmitis after topical use of IRX-101 combined with IVT
To evaluate the rate of infectious endophthalmitis after topical use of IRX-101 following intravitreal injection therapy (IVT) (% occurrence or rate of population randomized to IRX-101 test arm)
Time frame: 2 hours post-injection
Telephone questionnaire regarding patient-reported post-injection pain
Telephone questionnaire with questions asked of patients regarding patient-reported post-injection pain compared to Providone-Iodine Betadine control group (three questions asked scale of 0 to 10, 0 being no pain to 10 being worst pain)
Time frame: 2 hours post-injection
Plan to share: No
No publications or documents are linked to this record.
This study is terminated, as verified in May 2022. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: IRX-101
iRenix Medical, Inc.