InflammationPhase 3NCT02006888
The Efficacy and Safety of IBI-10090 for the Treatment of Inflammation Associated With Cataract Surgery
A Phase 3 study testing IBI-10090 in people with Inflammation and Cataracts, run by ICON Bioscience Inc at 1 site in United States.
Trial summary
The purpose of this study is to determine whether IBI-10090 injection is effective in the treatment of inflammation associated with cataract surgery. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Inflammation, Cataracts
- What is being tested?
- IBI-10090
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 394 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2014to Oct 2014
- Phase
- Phase 3
- 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The patient must provide written informed consent by signing the Informed Consent approved by the Institutional Review Board (IRB).
- Male or female patients at least 40 years of age scheduled for unilateral cataract surgery by phacoemulsification with posterior chamber intraocular lens implantation.
- The patient must demonstrate best corrected visual acuity (BCVA) of 20/30-20/200 (with glare testing, if necessary) in the study eye and better than 20/200 in the fellow eye.
- The patient must be considered by the Investigator to have visual acuity potential greater than 20/30 in the study eye.
- The patient must have a corneal endothelial cell count by specular microscopy in the study eye of at least 2000 cells/mm2 with normal cell morphology.
- A female patient of childbearing potential (premenopausal by medical history) must have a negative pregnancy test on Day 0 and be using an effective method of birth control (although no birth control method is 100% effective, the following are considered effective means of contraception: surgical sterilization, use of oral contraceptives, barrier contraception using either a condom or diaphragm with spermicidal gel, an intrauterine device, or contraceptive hormone implant or patch) from Screening for the duration of the study.
- The patient must be willing and able to understand and comply with the study procedures and to communicate meaningfully with study personnel.
Who cannot join
- Patients who have used any ocular, topical or oral corticosteroids within 7 days prior to Day 0.
- Patients who have received a periocular corticosteroid injection in the study eye in the 3 months prior to screening.
- Patients who have received any intravitreal corticosteroid delivery vehicle (e.g., Retisert, Ozurdex, Iluvien) in the study eye at any time.
- Patients who anticipate requiring treatment with any corticosteroids by any route, except inhalation, during the study.
- Patients with an allergy or hypersensitivity to dexamethasone.
- Patients who are known steroid responders (corticosteroid-related intraocular pressure elevation in either eye).
Show all 10Show fewer
- Patients who have used topical ocular NSAIDs in the study eye within 15 days prior to Day 0.
- Patients who have undergone prior intraocular (non-laser) surgery in the study eye within 6 months prior to screening.
- Patients who have undergone prior intraocular laser surgery in the study eye within 3 months prior to screening.
- Patients with planned intraocular or laser surgery in the study eye for the duration of the study.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to determine whether IBI-10090 injection is effective in the treatment of inflammation associated with cataract surgery.
Read the detailed description
A double blinded randomized trial to assess the efficacy and safety of IBI-10090, in two separate doses as compared to placebo (ATEC carrier only sans dexamethasone)
- Conditions
- Inflammation, Cataracts
- Being tested
- IBI-10090, Placebo
- Keywords
- Inflammation, cataract surgery
- Medical subject headings
- Inflammation, Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IBI-10090Drug
Also called Dexycu
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| IBI-10090 low dose | Experimental | IBI-10090 low dose Receives: Drug: IBI-10090 |
| IBI-10090 med dose | Experimental | IBI-10090 med dose Receives: Drug: IBI-10090 |
| Placebo | Placebo comparator | Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Anterior Chamber Cell Clearing
The primary efficacy outcome is anterior chamber cell clearing in the study eye at Day 8. The slit lamp examination for anterior chamber cells (ACC) is a recognized way to measure inflammation in the anterior chamber. During the slit lamp examination, the number of anterior chamber cells are quantified and graded: grade 0 (absent, 0 cells), grade 1 (1 to 5 cells), grade 2 (6 to 15 cells), grade 3 (16 to 30+ cells), or grade 4 (hypopyon). Anterior chamber cell clearing occurs when all the ACC are absent (grade 0).
Measured: Day 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2013 (estimated)
- Study startJan 2014
- Primary completionOct 2014
- Study completionOct 2014
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 InflammationStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 394 participants (actual)
Sponsor and investigators
- Lead sponsor
- ICON Bioscience Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- howard franklin, md, Study director, ICON Bioscience Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02006888
- Sponsor's protocol ID
- C13-04
- Status last verified
- Mar 2018
- First submitted
- 5 Dec 2013
- Last updated
- 23 Apr 2018
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy and Safety of IBI-10090 for the Treatment of Inflammation Associated With Cataract Surgery
- ClinicalTrials.gov ID
- NCT02006888
- Acronym / sponsor ID
- C13-04
- Conditions
- Inflammation, Cataracts
- Keywords
- Inflammation, cataract surgery
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 394 participants (actual)
- Lead sponsor
- ICON Bioscience IncIndustry (pharma, biotech, devices)
- Study start
- Jan 2014
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 10 Dec 2013 (estimated)
- Results
- Posted 23 Apr 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether IBI-10090 injection is effective in the treatment of inflammation associated with cataract surgery.
Detailed description
A double blinded randomized trial to assess the efficacy and safety of IBI-10090, in two separate doses as compared to placebo (ATEC carrier only sans dexamethasone)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| IBI-10090 low dose | Experimental | Drug: IBI-10090IBI-10090 low dose |
| IBI-10090 med dose | Experimental | Drug: IBI-10090IBI-10090 med dose |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- The patient must provide written informed consent by signing the Informed Consent approved by the Institutional Review Board (IRB).
- Male or female patients at least 40 years of age scheduled for unilateral cataract surgery by phacoemulsification with posterior chamber intraocular lens implantation.
- The patient must demonstrate best corrected visual acuity (BCVA) of 20/30-20/200 (with glare testing, if necessary) in the study eye and better than 20/200 in the fellow eye.
- The patient must be considered by the Investigator to have visual acuity potential greater than 20/30 in the study eye.
- The patient must have a corneal endothelial cell count by specular microscopy in the study eye of at least 2000 cells/mm2 with normal cell morphology.
Key exclusion criteria (10 listed)
- Patients who have used any ocular, topical or oral corticosteroids within 7 days prior to Day 0.
- Patients who have received a periocular corticosteroid injection in the study eye in the 3 months prior to screening.
- Patients who have received any intravitreal corticosteroid delivery vehicle (e.g., Retisert, Ozurdex, Iluvien) in the study eye at any time.
- Patients who anticipate requiring treatment with any corticosteroids by any route, except inhalation, during the study.
- Patients with an allergy or hypersensitivity to dexamethasone.
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 |
|---|---|---|
| IBI-10090Also: Dexycu | Drug | IBI-10090 low dose, IBI-10090 med dose |
| PlaceboPlacebo | Drug | Placebo |
Primary outcome
Number of Participants With Anterior Chamber Cell Clearing
Time frame: Day 8
The primary efficacy outcome is anterior chamber cell clearing in the study eye at Day 8. The slit lamp examination for anterior chamber cells (ACC) is a recognized way to measure inflammation in the anterior chamber. During the slit lamp examination, the number of anterior chamber cells are quantified and graded: grade 0 (absent, 0 cells), grade 1 (1 to 5 cells), grade 2 (6 to 15 cells), grade 3 (16 to 30+ cells), or grade 4 (hypopyon). Anterior chamber cell clearing occurs when all the ACC are absent (grade 0).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Inflammation
Not yet recruitingPhase 2/3
A Pivotal Safety and Immunogenicity GBS-NN/NN2 Vaccine Maternal Immunisation Trial
Streptococcus Agalactiae Infection, Neonatal Sepsis
RecruitingPhase 1
Pilot Study to Identify the Mediators and Inflammatory Cell Surface Receptors Involved in Allergic Airway Inflammation
Asthma
RecruitingPhase 4
Lidocaine Infiltration and Neuroimmunomodulation in Head and Neck Cancer Surgery
Head and Neck Cancer (H&N)
Active, not recruiting
CT for Personalized Mechanical Ventilation
Ventilator-Induced Lung Injury, Sepsis Syndrome
RecruitingPhase 4
A Study to Compare the Efficacy and Safety of Extended and Intermittent Infusion of Beta-lactams in Critically Ill Paediatric Patients
Infection, Sepsis
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.
howard franklin, md study director
ICON Bioscience Inc
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 IBI-10090 in people with Inflammation and Cataracts, run by ICON Bioscience 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 7 inclusion and 10 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 23 Apr 2018. 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. 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 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?
Yes. Results are posted in the registry (first posted 23 Apr 2018). 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?
Number of Participants With Anterior Chamber Cell Clearing (time frame: Day 8). 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 23 Apr 2018.