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Intracameral Versus Intravitreal Bevacizumab Injection in NVG: RCT

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ClinicalTrials.gov Identifier: NCT03648814
Recruitment Status : Recruiting
First Posted : August 27, 2018
Last Update Posted : August 27, 2018
Sponsor:
Information provided by (Responsible Party):
Weerawat Kiddee, Prince of Songkla University

Brief Summary:
To prospect studying the efficacy and safety of treating NVG with the intracameral versus the intravitreal injection of Bevacizumab.

Condition or disease Intervention/treatment Phase
Glaucoma, Neovascular Vascular Endothelial Growth Factor Overexpression Procedure: Intracameral injection Procedure: Intravitreal injection Not Applicable

Detailed Description:
The present study comparing the safety and efficacy of 1.25mg/0.05mL Bevacizumab injection via the intracameral route versus the intravitreal route in treating the neovascular glaucoma

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Intracameral Versus Intravitreal Bevacizumab Injection as an Adjunctive Therapy Before Trabeculectomy With Mitomycin-C in Neovascular Glaucoma: A Prospective Randomized Trial
Actual Study Start Date : August 1, 2018
Estimated Primary Completion Date : July 1, 2021
Estimated Study Completion Date : July 1, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma
Drug Information available for: Bevacizumab

Arm Intervention/treatment
Experimental: Intracameral injection
Intracameral Bevacizumab 1.25 mg/0.05 mL. Injection
Procedure: Intracameral injection
A/C injection of 1.25 mg/0.05 mL bevacizumab

Experimental: Intravitreal injection
Intravitreal Bevacizumab 1.25 mg/0.05 mL. Injection
Procedure: Intravitreal injection
Vitreous injection of 1.25 mg/0.05 mL bevacizumab




Primary Outcome Measures :
  1. regression of nevolascularization [ Time Frame: 2 months ]
    Amount of nevolascular of iris and angle regression


Secondary Outcome Measures :
  1. IOP reduction [ Time Frame: 2 months ]
    IOP reduction at 2-month visit compare to baseline

  2. Injection complication [ Time Frame: 2 days ]
    Hyphema, IOP spike



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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:

  1. Diagnosis of neovascular glaucoma
  2. The patients having IOP > 21 mmHg, having the indication for trabeculectomy
  3. The patients' age of at least 18-year-old
  4. The patients having visual potential at least hand motion.
  5. Present of NVI or NVA.
  6. Willing and able to provide informed consent to participate in the study
  7. Able to understand the purpose of the study, his/her role, and is available to return to the clinic/hospital for all required follow-up visits

Exclusion Criteria:

  1. One eye patient
  2. Patients having severe corneal edema or total hyphema obscure NVI or NVA view.
  3. Cannot obtain endothelial cell count.
  4. History of bevacizumab or fluorescence dye allergy.
  5. Active infectious ocular disease including endophthalmitis and corneal ulcer
  6. History of systemic disease including ischemic heart disease, cerebrovascular disease, end-stage renal disease, liver failure, uncontrolled hypertension
  7. Has or planning to be pregnant or breastfeeding

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): NCT03648814


Contacts
Contact: Assoc.Prof.Weerawat Kiddee, MD +66874954626 kweerawat@hotmail.com

Locations
Thailand
Glaucoma unit , Department of Ophthalmology Faculty of Medicine Prince of Songkla University Recruiting
Hat-yai, Songkhla, Thailand, 90110
Contact: WEERAWAT KIDDEE, MD    66-81271-0644    kweerawat@hotmail.com   
Sponsors and Collaborators
Prince of Songkla University
Investigators
Principal Investigator: Assoc.Prof.Weerawat Kiddee, MD Prince of Songkla University

Responsible Party: Weerawat Kiddee, Assoc. Prof., Prince of Songkla University
ClinicalTrials.gov Identifier: NCT03648814     History of Changes
Other Study ID Numbers: REC6100321
First Posted: August 27, 2018    Key Record Dates
Last Update Posted: August 27, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Weerawat Kiddee, Prince of Songkla University:
Neovascular glaucoma

Additional relevant MeSH terms:
Glaucoma
Glaucoma, Neovascular
Ocular Hypertension
Eye Diseases
Bevacizumab
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents