NCT04970251

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2018

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2021

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 24, 2021

Completed
27 days until next milestone

First Posted

Study publicly available on registry

July 21, 2021

Completed
Last Updated

July 21, 2021

Status Verified

July 1, 2021

Enrollment Period

2.4 years

First QC Date

June 24, 2021

Last Update Submit

July 11, 2021

Conditions

Intraocular PressureNeovascular GlaucomaVascular Endothelial Growth Factor OverexpressionGlaucoma Secondary to Eye Inflammation

Outcome Measures

Primary Outcomes (9)

  • Intraocular pressure

    Intraocular pressure after trabeculectomy

    Post-operative on day 1st

  • Intraocular pressure

    Intraocular pressure after trabeculectomy

    Post-operative on day 7th

  • Intraocular pressure

    Intraocular pressure after trabeculectomy

    Post-operative on month 3rd

  • Intraocular pressure

    Intraocular pressure after trabeculectomy

    Post-operative on month 6th

  • Intraocular pressure

    Intraocular pressure after trabeculectomy

    Post-operative on month 12th

  • Intraocular pressure

    Intraocular pressure after trabeculectomy

    Post-operative on month 18th

  • Intraocular pressure

    Intraocular pressure after trabeculectomy

    Post-operative on month 24th

  • Intraocular pressure

    Intraocular pressure after trabeculectomy

    Post-operative on month 30th

  • Intraocular pressure

    Intraocular pressure after trabeculectomy

    Post-operative on month 36th

Secondary Outcomes (12)

  • Visual acuity

    Post-operative on day 1st

  • Visual acuity

    Post-operative on day 7th

  • Visual acuity

    Post-operative on month 3rd

  • Visual acuity

    Post-operative on month 6th

  • Visual acuity

    Post-operative on month 12th

  • +7 more secondary outcomes

Interventions

Aflibercept OphthalmicDRUG

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.

Also known as: trabeculectomy, Panretinal photocoagulation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Naris Kitnarong

Bangkoknoi, Bangkok, 10700, Thailand

Location

Related Publications (3)

  • 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.

    PMID: 25812531RESULT

  • 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.

    PMID: 18425438RESULT

  • 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.

    PMID: 25580888RESULT

MeSH Terms

Conditions

Glaucoma, Neovascular

Interventions

Trabeculectomy

Condition Hierarchy (Ancestors)

GlaucomaOcular HypertensionEye Diseases

Intervention Hierarchy (Ancestors)

Filtering SurgeryOphthalmologic Surgical ProceduresSurgical Procedures, Operative

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

June 24, 2021

First Posted

July 21, 2021

Study Start

November 1, 2018

Primary Completion

March 31, 2021

Study Completion

March 31, 2021

Last Updated

July 21, 2021

Record last verified: 2021-07

Locations

TH(1)