Diabetic Macular EdemaPhase 3CLEANNCT05127525
EffiCacy, Safety and ToLErability of a Novel Ocular ANtiseptic for Ocular Use (CLEAN)
A Phase 3 study testing IRX-101 in people with Diabetic Macular Edema and Branch Retinal Vein Occlusion, run by iRenix Medical, Inc. at 1 site in United States.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diabetic Macular Edema, Branch Retinal Vein Occlusion, Glaucoma/Closed Angle Glaucoma
- What is being tested?
- IRX-101
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Nov 2021to 31 Jan 2022
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Capable of giving informed consent
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Male or female, ≥ 18 years of age and receiving intravitreal anti-VEGF injections in one or both eyes
Who cannot join
- Current or past diagnosis of endophthalmitis
- Current diagnosis of uveitis
- Current use of viscous lidocaine products for ocular anesthesia prior to IVT
- Currently receiving intravitreal steroid injections
- Concurrent participation in another clinical trial
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized, Double-Masked, Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of IRX-101 Versus 5% Povidone-Iodine as an Ocular Surface Sterilizer
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).
Read the detailed description
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.
- Being tested
- IRX-101, Control
- Medical subject headings
- Retinal Vein Occlusion, Glaucoma, Angle-Closure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IRX-101Drug
Also called Test Arm 1
IRX-101 to prevent infectious endophthalmitis following intravitreal injection therapy (IVT)
ControlDrug
Providone-Iodine Betadine to prevent infectious endophthalmitis following intravitreal injection therapy (IVT)
| Study group | Role | What they receive |
|---|---|---|
| Test Drug | Experimental | IRX-101 drops instilled prior to intravitreal injection Receives: Drug: IRX-101 |
| Control | Active comparator | Povidone-Iodine/Betadine drops instilled prior to intravitreal injection Receives: Drug: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 2 hours post-injection
Secondary outcomes (1)
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)
Measured: 2 hours post-injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2021
- Study start15 Nov 2021
- Primary completion31 Jan 2022
- Study completion31 Jan 2022
Why it stopped: Adverse event
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Macular EdemaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- iRenix Medical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Stephen Smith, MD, MS, Study chair, iRenix Medical
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05127525
- Sponsor's protocol ID
- IRX-2021-001
- Acronym
- CLEAN
- Status last verified
- May 2022
- First submitted
- 19 Oct 2021
- Last updated
- 24 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double-Masked, Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of IRX-101 Versus 5% Povidone-Iodine as an Ocular Surface Sterilizer
- ClinicalTrials.gov ID
- NCT05127525
- Acronym / sponsor ID
- CLEAN / IRX-2021-001
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Adverse event
- Enrolment
- 5 participants (actual)
- Lead sponsor
- iRenix Medical, Inc.Industry (pharma, biotech, devices)
- Study start
- 15 Nov 2021 (actual)
- Primary completion
- 31 Jan 2022 (actual)
- Study completion
- 31 Jan 2022 (actual)
- First posted
- 19 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test Drug | Experimental | Drug: IRX-101IRX-101 drops instilled prior to intravitreal injection |
| Control | Active comparator | Drug: ControlPovidone-Iodine/Betadine drops instilled prior to intravitreal injection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Capable of giving informed consent
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Male or female, ≥ 18 years of age and receiving intravitreal anti-VEGF injections in one or both eyes
Key exclusion criteria (5 listed)
- Current or past diagnosis of endophthalmitis
- Current diagnosis of uveitis
- Current use of viscous lidocaine products for ocular anesthesia prior to IVT
- Currently receiving intravitreal steroid injections
- Concurrent participation in another clinical trial
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IRX-101Also: Test Arm 1IRX-101 to prevent infectious endophthalmitis following intravitreal injection therapy (IVT) | Drug | Test Drug |
| ControlProvidone-Iodine Betadine to prevent infectious endophthalmitis following intravitreal injection therapy (IVT) | Drug | Control |
Primary outcome
Incidence of infectious endophthalmitis after topical use of IRX-101 combined with IVT
Time frame: 2 hours post-injection
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)
1 secondary outcome
Telephone questionnaire regarding patient-reported post-injection pain
Time frame: 2 hours post-injection
Results and safety
The study was stopped early (reason given: Adverse event). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2022.
- Individual participant dataSharing planned: No
Related trials for Diabetic Macular Edema
Active, not recruitingObservational study
Real World Evidence in China: Faricimab Use in Diabetic Macular Edema, Retinal Vein Occlusion, and Neovascular Age-Related Macular Degeneration (The Farseeing Study)
Diabetic Macular Edema, Neovascular Age-related Macular Degeneration
Active, not recruitingPhase 2
Long-Term Follow-Up Study of RGX-314 Administered in the Suprachoroidal Space for Participants With and Without Diabetic Retinopathy
Diabetic Retinopathy, DR
RecruitingPhase 3
A Phase 3 Trial for Intravitreal Injection of 4D-150 in Adults With Diabetic Macular Edema (DME).
Diabetic Macular Edema (DME)
RecruitingPhase 2
Oral N-Acetylcysteine on Diabetic Macular Edema
Diabetic Macular Edema (DME)
Active, not recruitingPhase 3
COMO: A Phase 3 Randomized, Double-Masked Study Comparing the Efficacy of EYP-1901 Against Aflibercept in DME
Diabetic Macular Edema, DME
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephen Smith, MD, MS study chair
iRenix Medical
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing IRX-101 in people with Diabetic Macular Edema and Branch Retinal Vein Occlusion, run by iRenix Medical, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 24 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Adverse event). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of infectious endophthalmitis after topical use of IRX-101 combined with IVT (time frame: 2 hours post-injection). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 May 2022.