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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03892434
Recruitment Status : Recruiting
First Posted : March 27, 2019
Last Update Posted : March 27, 2019
Sponsor:
Information provided by (Responsible Party):
Min Sagong, Yeungnam University College of Medicine

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).

Condition or disease Intervention/treatment Phase
Branch Retinal Vein Occlusion With Macular Edema Drug: Intravitreal bevacizumab and dexamethasone implant Injection Device: Intravitreal dexamethasone implant Phase 4

Detailed Description:

Retinal vein occlusion is the second most common retinal vessel disease following diabetic retinopathy. It is divided into central retinal vein occlusion and retinal vein occlusion. Visual disturbance resulting from retinal vein occlusion is mainly caused by macular edema, and one of the main mechanisms of macular edema is increased vascular endothelial growth factor. Increased vascular endothelial growth factor is known to cause macular edema by breaking blood retinal barrier and causing leakage. For this reason, intravitreal injection of anti - vascular endothelial growth factors is currently used to treat macular edema due to retinal vein occlusion. Corticosteroid is a different mechanism from anti - vascular endothelial growth factor, and it is the main mechanism to suppress macular edema, to suppress the expression of inflammatory mediators, to block the inflammatory reaction pathway, and to lower the vascular endothelial growth factor concentration in the vitreous body. The dexamethasone implant in the vitreous cavity showed the maximum visual improvement effect during 60 day after one injection, and the effect continued until about 90 days after the injection. The same effect was obtained with a fewer injection times compared to the injection of the anti-vascular endothelial growth factor and a variety of inflammatory. It is also effective in patients who do not respond to anti-vascular endothelial growth factors by effectively inhibiting cytokines and growth factors. However, steroids elevated intraocular pressure, it is limited in repeated use.

Intravitreal dexamethasone implantation and anti-vascular endothelial growth factor showed similar early vision improvement. The differences in these anatomical changes may be different in long-term visual prognosis. After 3 doses of loading dose of anti-vascular endothelial growth factor, each group was injected with anti-vascular endothelial growth factor (VEGF) at each recurrence of macular edema and injected with anti-vascular endothelial factor at each macular reattachment after dexamethasone injection. The results of this study are as follows.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Bevacizumab Versus DEX Implant Followed by Bevacizumab in ME Secondary to BRVO
Actual Study Start Date : March 18, 2019
Estimated Primary Completion Date : December 18, 2019
Estimated Study Completion Date : June 18, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Edema

Arm Intervention/treatment
Active Comparator: Bevacizumab Drug: Intravitreal bevacizumab and dexamethasone implant Injection
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.
Other Name: Intravitreal dexamethasone implant

Active Comparator: Dexamethasone Drug: Intravitreal bevacizumab and dexamethasone implant Injection
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.
Other Name: Intravitreal dexamethasone implant

Device: Intravitreal dexamethasone implant
Dexamethasone implant insertion using approved kit




Primary Outcome Measures :
  1. Mean change of best corrected visual acuity [ Time Frame: From baseline to Week 24 ]
    The mean change of best corrected visual acuity from baseline to Week 24 in Snellen visual acuity



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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).

Exclusion Criteria:

  • Previous PRP or macular laser photocoagulation in the study eye.
  • Any prior or concomitant ocular treatment (e.g. anti-VEGF therapy, corticosteroids) in the study eye for macular edema secondary to BRVO, except dietary supplements or vitamins prior to inclusion in the study. Intraocular anti-VEGF treatment is permitted for the treatment of diseases of fellow eye except for those that are specifically excluded.
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03892434


Contacts
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Contact: Min Sagong, MD 82-53-620-3443 msagong@ynu.ac.kr

Locations
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Korea, Republic of
Yeungnam university hospital Recruiting
Daegu, Korea, Republic of
Contact: Min Sagong, MD    82-53-620-3443    msagong@ynu.ac.kr   
Sponsors and Collaborators
Yeungnam University College of Medicine
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Responsible Party: Min Sagong, Associate Professor, Yeungnam University College of Medicine
ClinicalTrials.gov Identifier: NCT03892434    
Other Study ID Numbers: YUMC 2019-02-018
First Posted: March 27, 2019    Key Record Dates
Last Update Posted: March 27, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Macular Edema
Retinal Vein Occlusion
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Venous Thrombosis
Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Dexamethasone
Dexamethasone acetate
Bevacizumab
BB 1101
Antineoplastic Agents, Immunological
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists