Cataracts, Inflammation
Conditions
Keywords
Inflammation, cataract surgery
Brief summary
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)
Interventions
DRUGIBI-10090
DRUGPlacebo
Placebo
Sponsors
ICON Bioscience Inc
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. The patient must provide written informed consent by signing the Informed Consent approved by the Institutional Review Board (IRB). 2. Male or female patients at least 40 years of age scheduled for unilateral cataract surgery by phacoemulsification with posterior chamber intraocular lens implantation. 3. 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. 4. The patient must be considered by the Investigator to have visual acuity potential greater than 20/30 in the study eye. 5. 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. 6. 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. 7. The patient must be willing and able to understand and comply with the study procedures and to communicate meaningfully with study personnel. Key
Exclusion criteria
1. Patients who have used any ocular, topical or oral corticosteroids within 7 days prior to Day 0. 2. Patients who have received a periocular corticosteroid injection in the study eye in the 3 months prior to screening. 3. Patients who have received any intravitreal corticosteroid delivery vehicle (e.g., Retisert, Ozurdex, Iluvien) in the study eye at any time. 4. Patients who anticipate requiring treatment with any corticosteroids by any route, except inhalation, during the study. 5. Patients with an allergy or hypersensitivity to dexamethasone. 6. Patients who are known steroid responders (corticosteroid-related intraocular pressure elevation in either eye). 7. Patients who have used topical ocular NSAIDs in the study eye within 15 days prior to Day 0. 8. Patients who have undergone prior intraocular (non-laser) surgery in the study eye within 6 months prior to screening. 9. Patients who have undergone prior intraocular laser surgery in the study eye within 3 months prior to screening. 10. Patients with planned intraocular or laser surgery in the study eye for the duration of the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Anterior Chamber Cell Clearing | 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). |
Countries
United States
Participant flow
Recruitment details
The first patient was enrolled into the study on 19 December 2013 and the last patient completed the study on 03 October 2014.
Participants by arm
| Arm | Count |
|---|---|
| IBI-10090 Low Dose IBI-10090 low dose
IBI-10090 | 158 |
| IBI-10090 Med Dose IBI-10090 med dose
IBI-10090 | 156 |
| Placebo Placebo
Placebo: Placebo | 80 |
| Total | 394 |
Baseline characteristics
| Characteristic | IBI-10090 Low Dose | IBI-10090 Med Dose | Placebo | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 117 Participants | 115 Participants | 63 Participants | 295 Participants |
| Age, Categorical Between 18 and 65 years | 41 Participants | 41 Participants | 17 Participants | 99 Participants |
| Age, Continuous | 70 years STANDARD_DEVIATION 9 | 70 years STANDARD_DEVIATION 9 | 71 years STANDARD_DEVIATION 9 | 70 years STANDARD_DEVIATION 9 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 19 Participants | 23 Participants | 14 Participants | 56 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 139 Participants | 133 Participants | 66 Participants | 338 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 3 Participants | 0 Participants | 4 Participants |
| Race (NIH/OMB) Asian | 4 Participants | 1 Participants | 1 Participants | 6 Participants |
| Race (NIH/OMB) Black or African American | 17 Participants | 21 Participants | 11 Participants | 49 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 2 Participants | 1 Participants | 0 Participants | 3 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 5 Participants | 7 Participants | 1 Participants | 13 Participants |
| Race (NIH/OMB) White | 129 Participants | 123 Participants | 67 Participants | 319 Participants |
| Region of Enrollment United States | 158 participants | 156 participants | 80 participants | 394 participants |
| Sex: Female, Male Female | 75 Participants | 69 Participants | 39 Participants | 183 Participants |
| Sex: Female, Male Male | 83 Participants | 87 Participants | 41 Participants | 211 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 158 | 0 / 156 | 0 / 80 |
| other Total, other adverse events | 16 / 158 | 4 / 156 | 7 / 80 |
| serious Total, serious adverse events | 1 / 158 | 0 / 156 | 0 / 80 |
Outcome results
Primary
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).
Time frame: Day 8
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| IBI-10090 Low Dose | Number of Participants With Anterior Chamber Cell Clearing | 99 Participants |
| IBI-10090 Med Dose | Number of Participants With Anterior Chamber Cell Clearing | 103 Participants |
| Placebo | Number of Participants With Anterior Chamber Cell Clearing | 20 Participants |