The Efficacy and Safety of IBI-10090 for the Treatment of Inflammation Associated With Cataract Surgery

NCT02006888 | Completed Phase 3 Results

• 1 other identifier: C13-04
• Study Type: interventional
• Target: 394
• Locations: 1 country
• Sites: 1

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.

Conditions

Inflammation; Cataracts

Keywords

Inflammation; cataract surgery

Outcome Measures

Primary Outcomes (1)

• 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).

  Day 8

Study Arms (3)

IBI-10090 low dose

EXPERIMENTAL

IBI-10090 low dose

Drug: IBI-10090

IBI-10090 med dose

EXPERIMENTAL

IBI-10090 med dose

Drug: IBI-10090

Placebo

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

IBI-10090 DRUG

Also known as: Dexycu

IBI-10090 low dose; IBI-10090 med dose

Placebo DRUG

Placebo

Placebo

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).
• 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.

Sponsors & Collaborators

• ICON Bioscience Inc: lead

Study Sites (1)

Hull Eye Center

Lancaster, California, 93534, United States

Location

MeSH Terms

Conditions

Inflammation; Cataract

Interventions

Calcium Dobesilate

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Lens Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Benzenesulfonates; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Arylsulfonates; Arylsulfonic Acids; Sulfonic Acids; Sulfur Acids; Sulfur Compounds

Results Point of Contact

• Title: Howard Franklin
• Organization: IconBioscience

hfranklin@iconbioscience.com

2153961332

Study Officials

• howard franklin, md

  ICON Bioscience Inc

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 5, 2013
• First Posted: December 10, 2013
• Study Start: January 1, 2014
• Primary Completion: October 1, 2014
• Study Completion: October 1, 2014
• Last Updated: April 23, 2018
• Results First Posted: April 23, 2018

Record last verified: 2018-03

Locations

US (1)