Corneal Endothelial Cell LossPhase 2NCT02128113
RTA 408 Ophthalmic Suspension for the Prevention of Corneal Endothelial Cell Loss Following Cataract Surgery - GUARD
A Phase 2 study testing Omaveloxolone Ophthalmic Suspension 0.5% and Omaveloxolone Ophthalmic Suspension 1% in people with Corneal Endothelial Cell Loss and Ocular Pain, run by Biogen at 15 sites in United States.
Trial summary
This study assesses the efficacy and safety of two concentrations of omaveloxolone (RTA 408) ophthalmic suspension for the prevention of corneal endothelial cell loss following cataract surgery. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Corneal Endothelial Cell Loss, Ocular Pain, Ocular Inflammation
- What is being tested?
- Omaveloxolone Ophthalmic Suspension 0.5% and Omaveloxolone Ophthalmic Suspension 1%
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 307 participants
- Where
- 15 sitesUnited States
- Study dates
- 31 May 2014to 30 Apr 2015
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Be male or female and ≥18 years of age and ≤80 years of age
- Plan to undergo cataract extraction by phacoemulsification with the implantation of a posterior chamber intraocular lens
- Have the potential, in the opinion of the investigator, to improve best-corrected visual acuity in the study eye after surgery
- Have Grade 3, 4, or 5 nuclear cataract in the study eye, according to the LOCS III
- Have corneal endothelium in the study eye that can be accurately assessed using specular microscopy
- Have endothelial cell density of >1800 cells/mm2 in the study eye at the Screening Visit
- Have a pinhole visual acuity (VA) of at least 1.0 logarithm of the minimum angle of resolution (logMAR) in the study eye and fellow eye as measured using an Early Treatment for Diabetic Retinopathy Study (ETDRS) chart
Who cannot join
- Have a score >0 on the ocular pain assessment at the Screening Visit or the Randomization Visit in the study eye
- Have an active immunosuppressive disease or an autoimmune disease that, in the opinion of the investigator, could affect the quality of the ocular surface
- Have active or chronic/recurrent ocular or systemic disease that is uncontrolled and will likely affect wound healing
- Have an intraocular pressure (IOP) ≤5 mmHg in either eye
- Have had corneal or retinal surgery (laser or incisional) within the past 6 months, or be planning to have laser or incisional surgery during the study period in the study eye
- Have the presence of guttae Stage 2 or greater or other abnormality in the study eye that does not allow for accurate corneal endothelial cell assessments
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
United States15 sites
Argus Research
Cape Coral, Florida, 33904
Cincinnati Eye Institute
Cincinnati, Ohio, 45242
Chicago Cornea Consultants
Hoffman Estates, Illinois, 60169
Levenson Eye Associates
Jacksonville, Florida, 32204
Harvard Eye Associates
Laguna Hills, California, 92653
JacksonEye
Lake Villa, Illinois, 60046
Hull Eye Center
Lancaster, California, 93534
Discover Vision Centers
Leawood, Kansas, 66211
See Clearly Vision Group
McLean, Virginia, 22102
Alterman, Modi and Wolter
Poughkeepsie, New York, 12603
R & R Eye Research
San Antonio, Texas, 78229
Associated Eye Care
Stillwater, Minnesota, 55082
Opthalmic Consultants of Boston
Waltham, Massachusetts, 02451
Talamo Hatch Laser Eye Consultants
Waltham, Massachusetts, 02451
Comprehensive Eye Care
Washington, Missouri, 63090
About this study
Official title: A Multicenter, Randomized, Double-Masked, Vehicle-Controlled, Parallel-Group, Phase 2 Study of the Efficacy and Safety of RTA 408 For the Prevention of Corneal Endothelial Cell Loss in Patients Undergoing Cataract Surgery
This study assesses the efficacy and safety of two concentrations of omaveloxolone (RTA 408) ophthalmic suspension for the prevention of corneal endothelial cell loss following cataract surgery.
Read the detailed description
Many ocular diseases are characterized by oxidative stress and/or inflammation. Oxidative stress is also known to adversely impact corneal endothelial cells, and may be a factor resulting in the acute decrease in corneal endothelial cell density following ocular surgery. While corticosteroids provide potent anti-inflammatory efficacy in a wide range of acute and chronic inflammatory ocular diseases, their use is limited by their side effect profile, which includes the potential to elevate IOP and induce cataract formation. In addition, most available ophthalmic anti-inflammatory treatments, including corticosteroids, do not directly protect against the underlying oxidative stress component of the disease process. Consequently, there is a clinical need for agents that protect against oxidative stress and provide anti-inflammatory efficacy without inducing steroid-like side effects.
This study will assess the safety and efficacy of omaveloxolone (RTA 408) Ophthalmic Suspension (0.5% or 1%) versus vehicle for the prevention of corneal endothelial cell loss in patients undergoing cataract surgery.
- Being tested
- Vehicle Ophthalmic Solution, Omaveloxolone Ophthalmic Suspension 0.5%, Omaveloxolone Ophthalmic Suspension 1%
- Keywords
- RTA 408, Cataract surgery, Corneal Endothelial Cells, omaveloxolone
- Medical subject headings
- Corneal Endothelial Cell Loss, Eye Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vehicle Ophthalmic SolutionDrug
Opthalmic suspension manufactured to mimic RTA 408 suspension
Omaveloxolone Ophthalmic Suspension 0.5%Drug
Also called RTA 408 Ophthalmic Suspension 0.5%
0.5% ophthalmic suspension of RTA 408
Omaveloxolone Ophthalmic Suspension 1%Drug
Also called RTA 408 Ophthalmic Suspension 1%
1% ophthalmic suspension of RTA 408
| Study group | Role | What they receive |
|---|---|---|
| Vehicle Ophthalmic Solution | Placebo comparator | A single drop of Vehicle Ophthalmic solution was instilled into the study eye twice daily (approximately 12 hours apart) for a maximum of 28 days, beginning 3 to 7 days prior to cataract surgery and continuing on the day of surgery and for 3 weeks after surgery Receives: Drug: Vehicle Ophthalmic Solution |
| Omaveloxolone Opthalmic Suspension 0.5% | Experimental | A single drop of Omaveloxolone Ophthalmic suspension 0.5% was instilled into the study eye twice daily (approximately 12 hours apart) for a maximum of 28 days, beginning 3 to 7 days prior to cataract surgery and continuing on the day of surgery and for 3 weeks after surgery Receives: Drug: Omaveloxolone Ophthalmic Suspension 0.5% |
| Omaveloxolone Opthalmic Suspension 1% | Experimental | A single drop of Omaveloxolone Ophthalmic suspension 1.0% was instilled into the study eye twice daily (approximately 12 hours apart) for a maximum of 28 days, beginning 3 to 7 days prior to cataract surgery and continuing on the day of surgery and for 3 weeks after surgery Receives: Drug: Omaveloxolone Ophthalmic Suspension 1% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Central Corneal Endothelial Cell Counts
Count of central corneal endothelial cells 12 weeks post cataract surgery, compared to baseline
Measured: 12 weeks
Secondary outcomes (5)
Percentage of Patients With Absence of Anterior Chamber Cells at 2 Weeks After Cataract Surgery
Absence of of anterior chamber cells is defined as anterior chamber cells = 0
Measured: 2 weeks
Percentage of Patients With Absence of Anterior Chamber Flare at 2 Weeks After Cataract Surgery
Absence of of anterior chamber flare is defined as anterior chamber flare = 0
Measured: 2 weeks
Percentage of Patients With Clinical Cure (Absence of Anterior Chamber Cells + Flare) at 2 Weeks After Cataract Surgery
Absence of of anterior chamber cells + flare is defined as anterior chamber cells + flare = 0
Measured: 2 weeks
Percentage of Patients Who Were Pain Free 1 Day After Cataract Surgery
Measured: 1 day
Change From Baseline in Central Corneal Endothelial Cell Counts
Count of central corneal endothelial cells 6 weeks post cataract surgery, compared to baseline
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2014 (estimated)
- Study start31 May 2014
- Primary completion28 Feb 2015
- Study completion30 Apr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Corneal Endothelial Cell LossStudies of the same condition, open and under way.
- More trials run by BiogenThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 307 participants (actual)
Sponsor and investigators
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02128113
- Sponsor's protocol ID
- RTA 408-C-1309
- Status last verified
- May 2025
- First submitted
- 28 Apr 2014
- Last updated
- 3 Jun 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Yes: In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on https://www.biogentrialtransparency.com/
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-Masked, Vehicle-Controlled, Parallel-Group, Phase 2 Study of the Efficacy and Safety of RTA 408 For the Prevention of Corneal Endothelial Cell Loss in Patients Undergoing Cataract Surgery
- ClinicalTrials.gov ID
- NCT02128113
- Acronym / sponsor ID
- RTA 408-C-1309
- Keywords
- RTA 408, Cataract surgery, Corneal Endothelial Cells, omaveloxolone
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 307 participants (actual)
- Lead sponsor
- BiogenIndustry (pharma, biotech, devices)
- Collaborators
- AbbVie
- Study start
- 31 May 2014 (actual)
- Primary completion
- 28 Feb 2015 (actual)
- Study completion
- 30 Apr 2015 (actual)
- First posted
- 1 May 2014 (estimated)
- Results
- Posted 26 May 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study assesses the efficacy and safety of two concentrations of omaveloxolone (RTA 408) ophthalmic suspension for the prevention of corneal endothelial cell loss following cataract surgery.
Detailed description
Many ocular diseases are characterized by oxidative stress and/or inflammation. Oxidative stress is also known to adversely impact corneal endothelial cells, and may be a factor resulting in the acute decrease in corneal endothelial cell density following ocular surgery. While corticosteroids provide potent anti-inflammatory efficacy in a wide range of acute and chronic inflammatory ocular diseases, their use is limited by their side effect profile, which includes the potential to elevate IOP and induce cataract formation. In addition, most available ophthalmic anti-inflammatory treatments, including corticosteroids, do not directly protect against the underlying oxidative stress component of the disease process. Consequently, there is a clinical need for agents that protect against oxidative stress and provide anti-inflammatory efficacy without inducing steroid-like side effects.
This study will assess the safety and efficacy of omaveloxolone (RTA 408) Ophthalmic Suspension (0.5% or 1%) versus vehicle for the prevention of corneal endothelial cell loss in patients undergoing cataract surgery.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Vehicle Ophthalmic Solution | Placebo comparator | Drug: Vehicle Ophthalmic SolutionA single drop of Vehicle Ophthalmic solution was instilled into the study eye twice daily (approximately 12 hours apart) for a maximum of 28 days, beginning 3 to 7 days prior to cataract surgery and continuing on the day of surgery and for 3 weeks after surgery |
| Omaveloxolone Opthalmic Suspension 0.5% | Experimental | Drug: Omaveloxolone Ophthalmic Suspension 0.5%A single drop of Omaveloxolone Ophthalmic suspension 0.5% was instilled into the study eye twice daily (approximately 12 hours apart) for a maximum of 28 days, beginning 3 to 7 days prior to cataract surgery and continuing on the day of surgery and for 3 weeks after surgery |
| Omaveloxolone Opthalmic Suspension 1% | Experimental | Drug: Omaveloxolone Ophthalmic Suspension 1%A single drop of Omaveloxolone Ophthalmic suspension 1.0% was instilled into the study eye twice daily (approximately 12 hours apart) for a maximum of 28 days, beginning 3 to 7 days prior to cataract surgery and continuing on the day of surgery and for 3 weeks after surgery |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Be male or female and ≥18 years of age and ≤80 years of age
- Plan to undergo cataract extraction by phacoemulsification with the implantation of a posterior chamber intraocular lens
- Have the potential, in the opinion of the investigator, to improve best-corrected visual acuity in the study eye after surgery
- Have Grade 3, 4, or 5 nuclear cataract in the study eye, according to the LOCS III
- Have corneal endothelium in the study eye that can be accurately assessed using specular microscopy
Key exclusion criteria (6 listed)
- Have a score >0 on the ocular pain assessment at the Screening Visit or the Randomization Visit in the study eye
- Have an active immunosuppressive disease or an autoimmune disease that, in the opinion of the investigator, could affect the quality of the ocular surface
- Have active or chronic/recurrent ocular or systemic disease that is uncontrolled and will likely affect wound healing
- Have an intraocular pressure (IOP) ≤5 mmHg in either eye
- Have had corneal or retinal surgery (laser or incisional) within the past 6 months, or be planning to have laser or incisional surgery during the study period in the study eye
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 |
|---|---|---|
| Vehicle Ophthalmic SolutionOpthalmic suspension manufactured to mimic RTA 408 suspension | Drug | Vehicle Ophthalmic Solution |
| Omaveloxolone Ophthalmic Suspension 0.5%Also: RTA 408 Ophthalmic Suspension 0.5%0.5% ophthalmic suspension of RTA 408 | Drug | Omaveloxolone Opthalmic Suspension 0.5% |
| Omaveloxolone Ophthalmic Suspension 1%Also: RTA 408 Ophthalmic Suspension 1%1% ophthalmic suspension of RTA 408 | Drug | Omaveloxolone Opthalmic Suspension 1% |
Primary outcome
Change From Baseline in Central Corneal Endothelial Cell Counts
Time frame: 12 weeks
Count of central corneal endothelial cells 12 weeks post cataract surgery, compared to baseline
5 secondary outcomes
Percentage of Patients With Absence of Anterior Chamber Cells at 2 Weeks After Cataract Surgery
Time frame: 2 weeks
Percentage of Patients With Absence of Anterior Chamber Flare at 2 Weeks After Cataract Surgery
Time frame: 2 weeks
Percentage of Patients With Clinical Cure (Absence of Anterior Chamber Cells + Flare) at 2 Weeks After Cataract Surgery
Time frame: 2 weeks
Percentage of Patients Who Were Pain Free 1 Day After Cataract Surgery
Time frame: 1 day
Change From Baseline in Central Corneal Endothelial Cell Counts
Time frame: 6 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on https://www.biogentrialtransparency.com/
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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.
The record lists no contact. Use the official record to reach the sponsor.
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Omaveloxolone Ophthalmic Suspension 0.5% and Omaveloxolone Ophthalmic Suspension 1% in people with Corneal Endothelial Cell Loss and Ocular Pain, run by Biogen at 15 sites 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 7 inclusion and 6 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: finished, as of the sponsor's last update on 3 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 May 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change From Baseline in Central Corneal Endothelial Cell Counts (time frame: 12 weeks). 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 3 Jun 2025.