Bevacizumab Versus DEX Implant Followed by Bevacizumab in ME Secondary to BRVO

NCT03892434 | Unknown Phase 4 FDA Drug FDA Device

• 1 other identifier: YUMC 2019-02-018
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the efficacy of sequential therapy with intravitreal dexamethasone implant followed by bevacizumab compared with bevacizumab monotherapy for macular edema (ME) secondary to retinal vein occlusion (RVO).

Conditions

Branch Retinal Vein Occlusion With Macular Edema

Outcome Measures

Primary Outcomes (1)

• Mean change of best corrected visual acuity

  The mean change of best corrected visual acuity from baseline to Week 24 in Snellen visual acuity

  From baseline to Week 24

Study Arms (2)

Bevacizumab

ACTIVE COMPARATOR

Drug: Intravitreal bevacizumab and dexamethasone implant Injection

Dexamethasone

ACTIVE COMPARATOR

Drug: Intravitreal bevacizumab and dexamethasone implant Injection; Device: Intravitreal dexamethasone implant

Interventions

Intravitreal bevacizumab and dexamethasone implant Injection DRUG

Bevacizumab 1.25mg is injected into the vitreous cavity through the pars plana using 30G needle-attached syringe for branch retinal vein occlusion, and Dexamethasone 0.75mg implant is injected using injector.

Also known as: Intravitreal dexamethasone implant

Bevacizumab; Dexamethasone

Intravitreal dexamethasone implant DEVICE

Dexamethasone implant insertion using approved kit

Dexamethasone

Eligibility Criteria

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

You may qualify if:

• Center-involved macular edema secondary to BRVO for no longer than 3 months (at the screening visit it should be ensured that the subjects will comply with the criterion of ≤ 3 months since onset of macular edema at their scheduled baseline visit).

You may not qualify if:

• Previous PRP or macular laser photocoagulation in the study eye.
• Prior systemic anti-VEGF or corticosteroid therapy, investigational or approved, within the last 3 months before the first dose in the study.
• Previous use of intraocular corticosteroids in the study eye at any time or use of periocular corticosteroids in the study eye within 12 months prior to Day 1.
• Any active intraocular, extraocular, and periocular inflammation or infection in either eye within 4 weeks of screening.
• Any history of allergy to povidone iodine.
• Known serious allergy to the fluorescein sodium for injection in angiography.
• Presence of any contraindications indicated in the EU commission/locally approved label for intravitreal aflibercept: hypersensitivity to the active substance intravitreal aflibercept or to any of the excipients; active or suspected ocular or periocular infection; active severe intraocular inflammation.

Sponsors & Collaborators

• Yeungnam University College of Medicine: lead

Study Sites (1)

Yeungnam university hospital

Daegu, South Korea

RECRUITING

MeSH Terms

Interventions

Dexamethasone

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Central Study Contacts

Min Sagong, MD

CONTACT

82-53-620-3443; msagong@ynu.ac.kr

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: March 26, 2019
• First Posted: March 27, 2019
• Study Start: March 18, 2019
• Primary Completion: December 18, 2019
• Study Completion: June 18, 2020
• Last Updated: March 27, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)