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Aflibercept as Adjunctive Treatment for Filtration Surgery in Neovascular Glaucoma

Primary Purpose

Intraocular Pressure, Neovascular Glaucoma, Vascular Endothelial Growth Factor Overexpression

Status
Completed
Phase
Not Applicable
Locations
Thailand
Study Type
Interventional
Intervention
Aflibercept Ophthalmic
Sponsored by
Siriraj Hospital
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Intraocular Pressure

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Consecutive patients with neovascular glaucoma who presented at the Department of Ophthalmology, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand during November 2018 to October 2019.
  • Aged more than 18 year-old

Exclusion Criteria:

  • Patients who received any anti-vascular endothelial growth factor treatment before participation

Sites / Locations

  • Naris Kitnarong

Outcomes

Primary Outcome Measures

Intraocular pressure
Intraocular pressure after trabeculectomy
Intraocular pressure
Intraocular pressure after trabeculectomy
Intraocular pressure
Intraocular pressure after trabeculectomy
Intraocular pressure
Intraocular pressure after trabeculectomy
Intraocular pressure
Intraocular pressure after trabeculectomy
Intraocular pressure
Intraocular pressure after trabeculectomy
Intraocular pressure
Intraocular pressure after trabeculectomy
Intraocular pressure
Intraocular pressure after trabeculectomy
Intraocular pressure
Intraocular pressure after trabeculectomy

Secondary Outcome Measures

Visual acuity
Visual acuity of the studied eye
Visual acuity
Visual acuity of the studied eye
Visual acuity
Visual acuity of the studied eye
Visual acuity
Visual acuity of the studied eye
Visual acuity
Visual acuity of the studied eye
Visual acuity
Visual acuity of the studied eye
Visual acuity
Visual acuity of the studied eye
Visual acuity
Visual acuity of the studied eye
Visual acuity
Visual acuity of the studied eye
Numbers of medication
Numbers of anti-glaucoma medications
Numbers of medication
Numbers of anti-glaucoma medications
Numbers of medication
Numbers of anti-glaucoma medications

Full Information

First Posted
June 24, 2021
Last Updated
July 11, 2021
Sponsor
Siriraj Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04970251
Brief Title
Aflibercept as Adjunctive Treatment for Filtration Surgery in Neovascular Glaucoma
Official Title
Aflibercept as Adjunctive Treatment for Filtration Surgery in Neovascular
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
November 1, 2018 (Actual)
Primary Completion Date
March 31, 2021 (Actual)
Study Completion Date
March 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Siriraj Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Purpose: To investigate intravitreal aflibercept (IVA) injection as an adjunctive treatment to trabeculectomy with mitomycin C (TMC) and panretinal photocoagulation (PRP) for neovascular glaucoma (NVG). Setting: Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand Study design: Prospective interventional case series Methods: PRP and IVA (2 mg/0.05 ml) injection were given, and TMC was performed within 2 weeks after IVA. Additional PRP, laser suture lysis, subconjunctival 5-fluorouracil injection, and bleb needling were performed after TMC if indicated. Best-collected visual acuity (BCVA), intraocular pressure (IOP), surgical complications, and number of anti-glaucoma medications were collected.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intraocular Pressure, Neovascular Glaucoma, Vascular Endothelial Growth Factor Overexpression, Glaucoma Secondary to Eye Inflammation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
5 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Aflibercept Ophthalmic
Other Intervention Name(s)
trabeculectomy, Panretinal photocoagulation
Intervention Description
Panretinal photocoagulation and intravitreal aflibercept (2 mg/0.05 ml) injection were given, and trabeculectomy with mitomycin C was performed within 2 weeks after intravitreal aflibercept injection.
Primary Outcome Measure Information:
Title
Intraocular pressure
Description
Intraocular pressure after trabeculectomy
Time Frame
Post-operative on day 1st
Title
Intraocular pressure
Description
Intraocular pressure after trabeculectomy
Time Frame
Post-operative on day 7th
Title
Intraocular pressure
Description
Intraocular pressure after trabeculectomy
Time Frame
Post-operative on month 3rd
Title
Intraocular pressure
Description
Intraocular pressure after trabeculectomy
Time Frame
Post-operative on month 6th
Title
Intraocular pressure
Description
Intraocular pressure after trabeculectomy
Time Frame
Post-operative on month 12th
Title
Intraocular pressure
Description
Intraocular pressure after trabeculectomy
Time Frame
Post-operative on month 18th
Title
Intraocular pressure
Description
Intraocular pressure after trabeculectomy
Time Frame
Post-operative on month 24th
Title
Intraocular pressure
Description
Intraocular pressure after trabeculectomy
Time Frame
Post-operative on month 30th
Title
Intraocular pressure
Description
Intraocular pressure after trabeculectomy
Time Frame
Post-operative on month 36th
Secondary Outcome Measure Information:
Title
Visual acuity
Description
Visual acuity of the studied eye
Time Frame
Post-operative on day 1st
Title
Visual acuity
Description
Visual acuity of the studied eye
Time Frame
Post-operative on day 7th
Title
Visual acuity
Description
Visual acuity of the studied eye
Time Frame
Post-operative on month 3rd
Title
Visual acuity
Description
Visual acuity of the studied eye
Time Frame
Post-operative on month 6th
Title
Visual acuity
Description
Visual acuity of the studied eye
Time Frame
Post-operative on month 12th
Title
Visual acuity
Description
Visual acuity of the studied eye
Time Frame
Post-operative on month 18th
Title
Visual acuity
Description
Visual acuity of the studied eye
Time Frame
Post-operative on month 24th
Title
Visual acuity
Description
Visual acuity of the studied eye
Time Frame
Post-operative on month 30th
Title
Visual acuity
Description
Visual acuity of the studied eye
Time Frame
Post-operative on month 36th
Title
Numbers of medication
Description
Numbers of anti-glaucoma medications
Time Frame
Post-operative on month12th
Title
Numbers of medication
Description
Numbers of anti-glaucoma medications
Time Frame
Post-operative on month 24th
Title
Numbers of medication
Description
Numbers of anti-glaucoma medications
Time Frame
Post-operative on month 36th

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Consecutive patients with neovascular glaucoma who presented at the Department of Ophthalmology, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand during November 2018 to October 2019. Aged more than 18 year-old Exclusion Criteria: Patients who received any anti-vascular endothelial growth factor treatment before participation
Facility Information:
Facility Name
Naris Kitnarong
City
Bangkoknoi
State/Province
Bangkok
ZIP/Postal Code
10700
Country
Thailand

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
Centers who collect the data of neovascular Glaucoma patients who underwent intravitreal aflibercept injection, pan retinal photocoagulation and trabeculectomy with mitomycin C.
Citations:
PubMed Identifier
25812531
Citation
Kitnarong N, Sriyakul C, Chinwattanakul S. A Prospective Study to Evaluate Intravitreous Ranibizumab as Adjunctive Treatment for Trabeculectomy in Neovascular Glaucoma. Ophthalmol Ther. 2015 Jun;4(1):33-41. doi: 10.1007/s40123-015-0033-3. Epub 2015 Mar 27.
Results Reference
result
PubMed Identifier
18425438
Citation
Kitnarong N, Chindasub P, Metheetrairut A. Surgical outcome of intravitreal bevacizumab and filtration surgery in neovascular glaucoma. Adv Ther. 2008 May;25(5):438-43. doi: 10.1007/s12325-008-0047-5.
Results Reference
result
PubMed Identifier
25580888
Citation
Kobayashi S, Inoue M, Yamane S, Sakamaki K, Arakawa A, Kadonosono K. Long-term Outcomes After Preoperative Intravitreal Injection of Bevacizumab Before Trabeculectomy for Neovascular Glaucoma. J Glaucoma. 2016 Mar;25(3):281-4. doi: 10.1097/IJG.0000000000000211.
Results Reference
result

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Aflibercept as Adjunctive Treatment for Filtration Surgery in Neovascular Glaucoma

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