Aflibercept as Adjunctive Treatment for Filtration Surgery in Neovascular Glaucoma

July 11, 2021 updated by: Naris Kitnarong, Siriraj Hospital

Aflibercept as Adjunctive Treatment for Filtration Surgery in Neovascular

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

5

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Thailand
    • Bangkok
      • Bangkoknoi, Bangkok, Thailand, 10700
        • Naris Kitnarong

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intraocular pressure
Time Frame: Post-operative on day 1st
Intraocular pressure after trabeculectomy
Post-operative on day 1st
Intraocular pressure
Time Frame: Post-operative on day 7th
Intraocular pressure after trabeculectomy
Post-operative on day 7th
Intraocular pressure
Time Frame: Post-operative on month 3rd
Intraocular pressure after trabeculectomy
Post-operative on month 3rd
Intraocular pressure
Time Frame: Post-operative on month 6th
Intraocular pressure after trabeculectomy
Post-operative on month 6th
Intraocular pressure
Time Frame: Post-operative on month 12th
Intraocular pressure after trabeculectomy
Post-operative on month 12th
Intraocular pressure
Time Frame: Post-operative on month 18th
Intraocular pressure after trabeculectomy
Post-operative on month 18th
Intraocular pressure
Time Frame: Post-operative on month 24th
Intraocular pressure after trabeculectomy
Post-operative on month 24th
Intraocular pressure
Time Frame: Post-operative on month 30th
Intraocular pressure after trabeculectomy
Post-operative on month 30th
Intraocular pressure
Time Frame: Post-operative on month 36th
Intraocular pressure after trabeculectomy
Post-operative on month 36th

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual acuity
Time Frame: Post-operative on day 1st
Visual acuity of the studied eye
Post-operative on day 1st
Visual acuity
Time Frame: Post-operative on day 7th
Visual acuity of the studied eye
Post-operative on day 7th
Visual acuity
Time Frame: Post-operative on month 3rd
Visual acuity of the studied eye
Post-operative on month 3rd
Visual acuity
Time Frame: Post-operative on month 6th
Visual acuity of the studied eye
Post-operative on month 6th
Visual acuity
Time Frame: Post-operative on month 12th
Visual acuity of the studied eye
Post-operative on month 12th
Visual acuity
Time Frame: Post-operative on month 18th
Visual acuity of the studied eye
Post-operative on month 18th
Visual acuity
Time Frame: Post-operative on month 24th
Visual acuity of the studied eye
Post-operative on month 24th
Visual acuity
Time Frame: Post-operative on month 30th
Visual acuity of the studied eye
Post-operative on month 30th
Visual acuity
Time Frame: Post-operative on month 36th
Visual acuity of the studied eye
Post-operative on month 36th
Numbers of medication
Time Frame: Post-operative on month12th
Numbers of anti-glaucoma medications
Post-operative on month12th
Numbers of medication
Time Frame: Post-operative on month 24th
Numbers of anti-glaucoma medications
Post-operative on month 24th
Numbers of medication
Time Frame: Post-operative on month 36th
Numbers of anti-glaucoma medications
Post-operative on month 36th

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Siriraj Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2018

Primary Completion (Actual)

March 31, 2021

Study Completion (Actual)

March 31, 2021

Study Registration Dates

First Submitted

June 24, 2021

First Submitted That Met QC Criteria

July 11, 2021

First Posted (Actual)

July 21, 2021

Study Record Updates

Last Update Posted (Actual)

July 21, 2021

Last Update Submitted That Met QC Criteria

July 11, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Si726/2018

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

IPD Plan Description

Centers who collect the data of neovascular Glaucoma patients who underwent intravitreal aflibercept injection, pan retinal photocoagulation and trabeculectomy with mitomycin C.

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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