Evaluation of OZURDEX® in Patients With Macular Edema Secondary to Retinal Vein Occlusion in China

NCT03908307 | Completed Phase 4

• 1 other identifier: CMO-MA-EYE-0575
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 9

Brief Summary

This study will take place in China to evaluate the safety and efficacy of OZURDEX implant 700 μg in the treatment of macular edema due to retinal vein occlusion (RVO) in patients who have never received treatment for RVO.

Conditions

Macular Edema; Retinal Vein Occlusion

Outcome Measures

Primary Outcomes (3)

• Mean change in visual acuity from Baseline

  Determined by best corrected visual acuity (BCVA)

  At Month 6

• Proportion of patients with a BCVA improvement of 15 letters or more compared to Baseline

  Measured using the ETDRS visual acuity protocol

  At Month 6

• BCVA average change from Baseline in area under the curve (AUC) analysis

  At Month 6

Secondary Outcomes (10)

• Mean change from Baseline in BCVA

  After first follow-up visit, at each injection, and at Month 12

• Mean change from Baseline in Central Retinal Thickness (CRT)

  At Months 6 and 12

• Mean change from Baseline in the National Eye Institute (NEI) Visual Function Questionnaire (VFQ)-25

  At Months 6 and 12

• Mean number of OZURDEX injections

  During the 12-month study

• Mean retreatment interval in months

  During the 12-month study

Study Arms (1)

Study Eye

EXPERIMENTAL

OZURDEX implant 700 μg

Drug: OZURDEX

Interventions

OZURDEX DRUG

Implant 700 μg

Study Eye

Eligibility Criteria

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

You may qualify if:

• Patient diagnosed with macular edema due to RVO (either BRVO or CRVO, non-ischemic)
• Retinal thickness ≥ 300 μm by SD-OCT in the central 1 mm macular subfield of the study eye at the Screening visit
• BCVA score of 19 to 73 letters (approximately 20/400 to 20/40 Snellen equivalent) in the study eye measured by ETDRS method at Screening
• \< 3 months of macular edema duration
• Treatment-naive patients (ie, have not previously received any treatment for macular edema secondary to RVO)

You may not qualify if:

• Uncontrolled systemic disease
• Presence of/history of any ocular condition other than macular edema that affects visual acuity (eg, cataract, severe macular ischemia, foveal atrophy, age-related macular degeneration, uveitis or other ocular inflammatory disease, neovascular glaucoma, Irvine-Gass syndrome, prior macular detachment)
• Any of the following ≤ 3 months before study entry or anticipated need within the coming 3 months:
• Intraocular surgery
• Laser photocoagulation
• Intraocular injection
• Periocular steroid injection
• Vitrectomized eye
• Aphakic eyes with ruptured posterior lens capsule or presence of an ACIOL, iris or transscleral fixated intraocular lens
• History of marked IOP elevation in response to steroid treatment that (a) required IOP-lowering treatment, (b) resulted in a \>10 mm Hg increase in IOP from predose, or (c) resulted in IOP \>25 mm Hg
• History of glaucoma or ocular hypertension (IOP \> 21 mm Hg), or optic nerve head change consistent with glaucoma damage, and/or glaucomatous visual field loss in the study eye (patients with a history of previous angle closure that has been successfully treated with either a laser or surgical peripheral iridotomy \[PI\] are allowed as long as the visual fields have been stable for \> 1 year prior to study entry and the patient has been and can be safely dilated).
• Any active ocular infection (i.e., bacterial, viral, parasitic, or fungal) in either eye at the Screening visit
• Female patients who are pregnant, nursing, or planning a pregnancy, or who are of childbearing potential and not using a reliable means of contraception
• Any condition that may interfere or preclude participation in the study
• Use of systemic steroids (e.g., oral, intravenous, intramuscular, epidural, rectal, or extensive dermal) within 1 month prior to Baseline or anticipated use at any time during the study (inhaled, intranasal, and intra-articular/intrabursal corticosteroids are allowed)

Sponsors & Collaborators

• Allergan: lead

Study Sites (9)

Peking Union Medical College Hospital /ID# 233616

Beijing, Beijing Municipality, 100730, China

Location

Beijing Tongren Hospital, CMU /ID# 233608

Beijing, 100730, China

Location

The First Xiangya Hospital of Central South University /ID# 233627

Changsha Hunan, 410008, China

Location

The First Affiliated Hospital of Dalian Medical University /ID# 233688

Dalian, 116011, China

Location

Qilu Hospital of Shandong University /ID# 233605

Jinan, 250012, China

Location

The Eye and ENT Hospital Affiliated of Fudan Univesity /ID# 233666

Shanghai, 200031, China

Location

Shanghai General Hospital /ID# 233579

Shanghai, 200080, China

Location

Joint Shantou International Eye Center of Shantou University and The Chinese Uni /ID# 233580

Shantou, 515041, China

Location

Tianjin Eye Hospital /ID# 233581

Tianjin, 300020, China

Location

Related Links

• clinical study report synopsis

MeSH Terms

Conditions

Macular Edema; Retinal Vein Occlusion

Interventions

Calcium Dobesilate

Condition Hierarchy (Ancestors)

Macular Degeneration; Retinal Degeneration; Retinal Diseases; Eye Diseases; Venous Thrombosis; Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

• ALLERGAN INC.

  Allergan

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 28, 2019
• First Posted: April 9, 2019
• Study Start: July 25, 2019
• Primary Completion: September 26, 2021
• Study Completion: September 26, 2021
• Last Updated: March 31, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: For details on when studies are available for sharing, please refer to the link below
• Access Criteria: Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Use Agreement (DUA). For more information on the process, or to submit a request, visit the following link.

Locations

CN (9)