Efficacy and Safety Study of IBI-10090 in Patients Undergoing Cataract Surgery

• Sponsor: ICON Bioscience Inc (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT01048593
• Collaborator: (none)
• Enrollment: 6
• Location: 1
• Arms: 3
• Duration (Months): 5
• Patients Per Site Per Month: 1.2

Study Details

Study Description

Brief Summary

This study will test the efficacy and safety of IBI-10090 for the reduction of ocular inflammation after cataract surgery.

Condition or Disease	Intervention/Treatment	Phase
Inflammatory Reaction Due to Ocular Lens Prosthesis	Drug: IBI-10090	Phase 2

Detailed Description

All patients received active treatment in this study. Dose group 1 received 114ug of dexamethasone, Dose group 2 received 513ug and Dose group 3 received 684ug.

Study Design

• Study Type: Interventional
• Actual Enrollment: 6 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Multicenter, Randomized, Double-masked, Dose-ranging, Phase 2 Study to Evaluate the Efficacy and Safety of IBI-10090 in Cataract Surgery Patients
• Study Start Date: Jan 1, 2010
• Actual Primary Completion Date: May 1, 2010
• Actual Study Completion Date: Jun 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Dose 1 114ug	Drug: IBI-10090; Single intraocular injection
Experimental: Dose 2 513ug	Drug: IBI-10090; Single intraocular injection
Experimental: Dose 3 684ug	Drug: IBI-10090; Single intraocular injection

Outcome Measures

Primary Outcome Measures

1. Clearance of Anterior Chamber Cells [Day 8 post treatment]

   Efficacy was assessed by slit lamp biomicroscopy to evaluate the anterior chamber cells (ACC) graded on a scale of 0 to 4. The primary efficacy endpoint was complete clearing of ACC, where grade 0 = 0 cells in the anterior chamber on POD 8.

Secondary Outcome Measures

1. Anterior Chamber Flare (ACF) Grade [Day 90 post-treatment]

   Efficacy was assessed by slit lamp biomicroscopy to evaluate the anterior chamber flare (ACF) graded on a scale of 0 to 4.

2. Conjunctival Erythema Grade [Day 90 post-treatment]

   Conjunctival erythema was evaluated by slit lamp biomicroscopy graded on a scale of 0 to 3.

3. Corneal Edema Grade [Day 90 post-treatment]

   Cornea edema was evaluated by slit lamp biomicroscopy graded on a scale of 0 to 3.

4. Anterior Chamber Cell Grade [Day 90 post-treatment]

   Anterior chamber cells (ACC) grade was evaluated by slit lamp biomicroscopy graded on a scale of 0 to 4.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 40 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Male or female patients 40 years of age scheduled for unilateral cataract surgery (phacoemulsification or extracapsular extraction) with posterior chamber intraocular lens implantation.

Exclusion Criteria:

• Patients who have used any ocular, topical or oral corticosteroids within 7 days prior to Day 0.

• Patients who have used topical ocular NSAIDs in the study eye within 15 days prior to screening.

• Patients with any signs of intraocular inflammation in either eye at screening.

• Patients who have received any prior intravitreal injections in the study eye.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Altos Eye Physicians	Los Altos	California	United States	94024

Sponsors and Collaborators

• ICON Bioscience Inc

Investigators

• Principal Investigator: David Chang, MD, Altos Eye Physicians

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: ICON Bioscience Inc
• ClinicalTrials.gov Identifier: NCT01048593
• Other Study ID Numbers: C09-01
• First Posted: Jan 13, 2010
• Last Update Posted: Dec 4, 2018
• Last Verified: Nov 1, 2018

• Keywords provided by ICON Bioscience Inc: ocular inflammation cataract surgery; post cataract surgery inflammation
• Additional relevant MeSH terms: Cataract; Inflammation

Study Results

Participant Flow

Arm/Group Title	Dose 1	Dose 2	Dose 3
Arm/Group Description	114ug dose group	513ug dose group	684ug dose group
Period Title: Overall Study
STARTED	3	2	1
COMPLETED	3	2	1
NOT COMPLETED	0	0	0

Baseline Characteristics

Arm/Group Title	Dose 1	Dose 2	Dose 3	Total
Arm/Group Description	114ug dose group	513ug dose group	684ug dose group	Total of all reporting groups
Overall Participants	3	2	1	6
Age, Customized (participants) [Number]
<=18 years	0 0%	0 0%	0 0%	0 0%
Between 18 and 65 years	3 100%	2 100%	1 100%	6 100%
>=65 years	0 0%	0 0%	0 0%	0 0%
Sex/Gender, Customized (participants) [Number]
Female	0 0%	0 0%	0 0%	0 0%
Male	0 0%	0 0%	0 0%	0 0%
Unknown	3 100%	2 100%	1 100%	6 100%

Outcome Measures

1. Primary Outcome

Title	Clearance of Anterior Chamber Cells
Description	Efficacy was assessed by slit lamp biomicroscopy to evaluate the anterior chamber cells (ACC) graded on a scale of 0 to 4. The primary efficacy endpoint was complete clearing of ACC, where grade 0 = 0 cells in the anterior chamber on POD 8.
Time Frame	Day 8 post treatment

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Dose 1	Dose 2	Dose 3
Arm/Group Description	114ug IBI-10090: Single intraocular injection	513ug IBI-10090: Single intraocular injection	684ug IBI-10090: Single intraocular injection
Measure Participants	3	2	1
Grade 0 (absent)	3 100%	2 100%	1 100%
Grade 1 (1-5 cells)	0 0%	0 0%	0 0%
Grade 2 (6-15 cells)	0 0%	0 0%	0 0%
Grade 3 (16-30 cells)	0 0%	0 0%	0 0%
Grade 4 (hypopyon)	0 0%	0 0%	0 0%
Grade 0 (absent)	0 0%	0 0%	1 100%
Grade 1 (1-5 cells)	1 33.3%	0 0%	0 0%
Grade 2 (6-15 cells)	1 33.3%	1 50%	0 0%
Grade 3 (16-30 cells)	1 33.3%	1 50%	0 0%
Grade 4 (hypopyon)	0 0%	0 0%	0 0%

2. Secondary Outcome

Title	Anterior Chamber Flare (ACF) Grade
Description	Efficacy was assessed by slit lamp biomicroscopy to evaluate the anterior chamber flare (ACF) graded on a scale of 0 to 4.
Time Frame	Day 90 post-treatment

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Dose 1	Dose 2	Dose 3
Arm/Group Description	114ug IBI-10090: Single intraocular injection	513ug IBI-10090: Single intraocular injection	684ug IBI-10090: Single intraocular injection
Measure Participants	3	2	1
Grade 0 (absent)	3 100%	2 100%	1 100%
Grade 1 (trace)	0 0%	0 0%	0 0%
Grade 2 (mild intensity)	0 0%	0 0%	0 0%
Grade 3 (moderate Intensity)	0 0%	0 0%	0 0%
Grade 4 (strong intensity)	0 0%	0 0%	0 0%
Grade 0 (absent)	1 33.3%	1 50%	0 0%
Grade 1 (trace)	0 0%	0 0%	0 0%
Grade 2 (mild intensity)	2 66.7%	1 50%	1 100%
Grade 3 (moderate Intensity)	0 0%	0 0%	0 0%
Grade 4 (strong intensity)	0 0%	0 0%	0 0%
Grade 0 (absent)	1 33.3%	1 50%	1 100%
Grade 1 (trace)	1 33.3%	0 0%	0 0%
Grade 2 (mild intensity)	1 33.3%	1 50%	0 0%
Grade 3 (moderate Intensity)	0 0%	0 0%	0 0%
Grade 4 (strong intensity)	0 0%	0 0%	0 0%
Grade 0 (absent)	0 0%	1 50%	1 100%
Grade 1 (trace)	1 33.3%	0 0%	0 0%
Grade 2 (mild intensity)	1 33.3%	1 50%	0 0%
Grade 3 (moderate Intensity)	1 33.3%	0 0%	0 0%
Grade 4 (strong intensity)	0 0%	0 0%	0 0%
Grade 0 (absent)	1 33.3%	1 50%	1 100%
Grade 1 (trace)	1 33.3%	0 0%	0 0%
Grade 2 (mild intensity)	1 33.3%	1 50%	0 0%
Grade 3 (moderate Intensity)	0 0%	0 0%	0 0%
Grade 4 (strong intensity)	0 0%	0 0%	0 0%
Grade 0 (absent)	3 100%	1 50%	1 100%
Grade 1 (trace)	0 0%	0 0%	0 0%
Grade 2 (mild intensity)	0 0%	1 50%	0 0%
Grade 3 (moderate Intensity)	0 0%	0 0%	0 0%
Grade 4 (strong intensity)	0 0%	0 0%	0 0%
Grade 0 (absent)	3 100%	2 100%	1 100%
Grade 1 (trace)	0 0%	0 0%	0 0%
Grade 2 (mild intensity)	0 0%	0 0%	0 0%
Grade 3 (moderate Intensity)	0 0%	0 0%	0 0%
Grade 4 (strong intensity)	0 0%	0 0%	0 0%

3. Secondary Outcome

Title	Conjunctival Erythema Grade
Description	Conjunctival erythema was evaluated by slit lamp biomicroscopy graded on a scale of 0 to 3.
Time Frame	Day 90 post-treatment

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Dose 1	Dose 2	Dose 3
Arm/Group Description	114ug IBI-10090: Single intraocular injection	513ug IBI-10090: Single intraocular injection	684ug IBI-10090: Single intraocular injection
Measure Participants	3	2	1
Grade 0 (no erythema)	3 100%	2 100%	1 100%
Grade 1 (pale reddish bulbar)	0 0%	0 0%	0 0%
Grade 2 (red bulbar)	0 0%	0 0%	0 0%
Grade 3 (bright red bulbar)	0 0%	0 0%	0 0%
Grade 0 (no erythema)	3 100%	1 50%	1 100%
Grade 1 (pale reddish bulbar)	0 0%	1 50%	0 0%
Grade 2 (red bulbar)	0 0%	0 0%	0 0%
Grade 3 (bright red bulbar)	0 0%	0 0%	0 0%
Grade 0 (no erythema)	1 33.3%	2 100%	1 100%
Grade 1 (pale reddish bulbar)	1 33.3%	0 0%	0 0%
Grade 2 (red bulbar)	1 33.3%	0 0%	0 0%
Grade 3 (bright red bulbar)	0 0%	0 0%	0 0%
Grade 0 (no erythema)	1 33.3%	2 100%	1 100%
Grade 1 (pale reddish bulbar)	0 0%	0 0%	0 0%
Grade 2 (red bulbar)	2 66.7%	0 0%	0 0%
Grade 3 (bright red bulbar)	0 0%	0 0%	0 0%
Grade 0 (no erythema)	1 33.3%	1 50%	1 100%
Grade 1 (pale reddish bulbar)	1 33.3%	1 50%	0 0%
Grade 2 (red bulbar)	1 33.3%	0 0%	0 0%
Grade 3 (bright red bulbar)	0 0%	0 0%	0 0%
Grade 0 (no erythema)	3 100%	2 100%	1 100%
Grade 1 (pale reddish bulbar)	0 0%	0 0%	0 0%
Grade 2 (red bulbar)	0 0%	0 0%	0 0%
Grade 3 (bright red bulbar)	0 0%	0 0%	0 0%
Grade 0 (no erythema)	3 100%	2 100%	1 100%
Grade 1 (pale reddish bulbar)	0 0%	0 0%	0 0%
Grade 2 (red bulbar)	0 0%	0 0%	0 0%
Grade 3 (bright red bulbar)	0 0%	0 0%	0 0%

4. Secondary Outcome

Title	Corneal Edema Grade
Description	Cornea edema was evaluated by slit lamp biomicroscopy graded on a scale of 0 to 3.
Time Frame	Day 90 post-treatment

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Dose 1	Dose 2	Dose 3
Arm/Group Description	114ug IBI-10090: Single intraocular injection	513ug IBI-10090: Single intraocular injection	684ug IBI-10090: Single intraocular injection
Measure Participants	3	2	1
Grade 0 (absent)	3 100%	2 100%	1 100%
Grade 1 (mild edema)	0 0%	0 0%	0 0%
Grade 2 (moderate edema)	0 0%	0 0%	0 0%
Grade 3 (severe edema)	0 0%	0 0%	0 0%
Grade 0 (absent)	3 100%	1 50%	0 0%
Grade 1 (mild edema)	0 0%	1 50%	1 100%
Grade 2 (moderate edema)	0 0%	0 0%	0 0%
Grade 3 (severe edema)	0 0%	0 0%	0 0%
Grade 0 (absent)	3 100%	1 50%	1 100%
Grade 1 (mild edema)	0 0%	1 50%	0 0%
Grade 2 (moderate edema)	0 0%	0 0%	0 0%
Grade 3 (severe edema)	0 0%	0 0%	0 0%
Grade 0 (absent)	3 100%	1 50%	1 100%
Grade 1 (mild edema)	0 0%	1 50%	0 0%
Grade 2 (moderate edema)	0 0%	0 0%	0 0%
Grade 3 (severe edema)	0 0%	0 0%	0 0%
Grade 0 (absent)	3 100%	2 100%	1 100%
Grade 1 (mild edema)	0 0%	0 0%	0 0%
Grade 2 (moderate edema)	0 0%	0 0%	0 0%
Grade 3 (severe edema)	0 0%	0 0%	0 0%
Grade 0 (absent)	3 100%	2 100%	1 100%
Grade 1 (mild edema)	0 0%	0 0%	0 0%
Grade 2 (moderate edema)	0 0%	0 0%	0 0%
Grade 3 (severe edema)	0 0%	0 0%	0 0%
Grade 0 (absent)	3 100%	2 100%	1 100%
Grade 1 (mild edema)	0 0%	0 0%	0 0%
Grade 2 (moderate edema)	0 0%	0 0%	0 0%
Grade 3 (severe edema)	0 0%	0 0%	0 0%

5. Secondary Outcome

Title	Anterior Chamber Cell Grade
Description	Anterior chamber cells (ACC) grade was evaluated by slit lamp biomicroscopy graded on a scale of 0 to 4.
Time Frame	Day 90 post-treatment

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Dose 1	Dose 2	Dose 3
Arm/Group Description	114ug IBI-10090: Single intraocular injection	513ug IBI-10090: Single intraocular injection	684ug IBI-10090: Single intraocular injection
Measure Participants	3	2	1
Grade 0 (absent)	3 100%	2 100%	1 100%
Grade 1 (1-5 cells)	0 0%	0 0%	0 0%
Grade 2 (6-15 cells)	0 0%	0 0%	0 0%
Grade 3 (16-30 cells)	0 0%	0 0%	0 0%
Grade 4 (hypopyon)	0 0%	0 0%	0 0%
Grade 0 (absent)	0 0%	0 0%	0 0%
Grade 1 (1-5 cells)	1 33.3%	1 50%	0 0%
Grade 2 (6-15 cells)	2 66.7%	0 0%	0 0%
Grade 3 (16-30 cells)	0 0%	1 50%	1 100%
Grade 4 (hypopyon)	0 0%	0 0%	0 0%
Grade 0 (absent)	0 0%	0 0%	0 0%
Grade 1 (1-5 cells)	0 0%	1 50%	1 100%
Grade 2 (6-15 cells)	2 66.7%	0 0%	0 0%
Grade 3 (16-30 cells)	1 33.3%	1 50%	0 0%
Grade 4 (hypopyon)	0 0%	0 0%	0 0%
Grade 0 (absent)	0 0%	0 0%	1 100%
Grade 1 (1-5 cells)	0 0%	1 50%	0 0%
Grade 2 (6-15 cells)	2 66.7%	0 0%	0 0%
Grade 3 (16-30 cells)	1 33.3%	1 50%	0 0%
Grade 4 (hypopyon)	0 0%	0 0%	0 0%
Grade 0 (absent)	0 0%	0 0%	0 0%
Grade 1 (1-5 cells)	1 33.3%	2 100%	1 100%
Grade 2 (6-15 cells)	2 66.7%	0 0%	0 0%
Grade 3 (16-30 cells)	0 0%	0 0%	0 0%
Grade 4 (hypopyon)	0 0%	0 0%	0 0%
Grade 0 (absent)	3 100%	1 50%	1 100%
Grade 1 (1-5 cells)	0 0%	1 50%	0 0%
Grade 2 (6-15 cells)	0 0%	0 0%	0 0%
Grade 3 (16-30 cells)	0 0%	0 0%	0 0%
Grade 4 (hypopyon)	0 0%	0 0%	0 0%
Grade 0 (absent)	3 100%	2 100%	1 100%
Grade 1 (1-5 cells)	0 0%	0 0%	0 0%
Grade 2 (6-15 cells)	0 0%	0 0%	0 0%
Grade 3 (16-30 cells)	0 0%	0 0%	0 0%
Grade 4 (hypopyon)	0 0%	0 0%	0 0%

Adverse Events

Arm/Group Title	Dose 1		Dose 2		Dose 3
Arm/Group Description	114ug dose group		513ug dose group		684ug dose group
All Cause Mortality
	Dose 1		Dose 2		Dose 3
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Dose 1		Dose 2		Dose 3
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/3 (0%)		0/2 (0%)		0/1 (0%)
Other (Not Including Serious) Adverse Events
	Dose 1		Dose 2		Dose 3
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/3 (33.3%)		1/2 (50%)		1/1 (100%)
General disorders
nasopharyngitis	1/3 (33.3%)	1	0/2 (0%)	0	0/1 (0%)	0
skin infection	0/3 (0%)	0	1/2 (50%)	1	0/1 (0%)	0
rash	0/3 (0%)	0	0/2 (0%)	0	1/1 (100%)	1
Musculoskeletal and connective tissue disorders
myalgia	1/3 (33.3%)	1	0/2 (0%)	0	0/1 (0%)	0

Limitations/Caveats

Early termination leading to small numbers of subjects analyzed.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.