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OpenTrials
Completed

NCT Number: NCT04970251

Aflibercept as Adjunctive Treatment for Filtration Surgery in Neovascular Glaucoma

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.

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Key information

Conditions

Intraocular Pressure Eye Diseases Glaucoma Glaucoma Secondary to Eye Inflammation Glaucoma, Neovascular Neovascular Glaucoma Ocular Hypertension Vascular Endothelial Growth Factor Overexpression

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Naris Kitnarong

Bangkoknoi, Bangkok, 10700, Thailand

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Aflibercept Ophthalmic

Drug

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.

Other names: trabeculectomy, Panretinal photocoagulation

Primary outcomes

  1. Intraocular pressure

    Time frame: Post-operative on day 1st

    Intraocular pressure after trabeculectomy

  2. Intraocular pressure

    Time frame: Post-operative on day 7th

    Intraocular pressure after trabeculectomy

  3. Intraocular pressure

    Time frame: Post-operative on month 3rd

    Intraocular pressure after trabeculectomy

  4. Intraocular pressure

    Time frame: Post-operative on month 6th

    Intraocular pressure after trabeculectomy

  5. Intraocular pressure

    Time frame: Post-operative on month 12th

    Intraocular pressure after trabeculectomy

  6. Intraocular pressure

    Time frame: Post-operative on month 18th

    Intraocular pressure after trabeculectomy

  7. Intraocular pressure

    Time frame: Post-operative on month 24th

    Intraocular pressure after trabeculectomy

  8. Intraocular pressure

    Time frame: Post-operative on month 30th

    Intraocular pressure after trabeculectomy

  9. Intraocular pressure

    Time frame: Post-operative on month 36th

    Intraocular pressure after trabeculectomy

Secondary outcomes

  1. Visual acuity

    Time frame: Post-operative on day 1st

    Visual acuity of the studied eye

  2. Visual acuity

    Time frame: Post-operative on day 7th

    Visual acuity of the studied eye

  3. Visual acuity

    Time frame: Post-operative on month 3rd

    Visual acuity of the studied eye

  4. Visual acuity

    Time frame: Post-operative on month 6th

    Visual acuity of the studied eye

  5. Visual acuity

    Time frame: Post-operative on month 12th

    Visual acuity of the studied eye

  6. Visual acuity

    Time frame: Post-operative on month 18th

    Visual acuity of the studied eye

  7. Visual acuity

    Time frame: Post-operative on month 24th

    Visual acuity of the studied eye

  8. Visual acuity

    Time frame: Post-operative on month 30th

    Visual acuity of the studied eye

  9. Visual acuity

    Time frame: Post-operative on month 36th

    Visual acuity of the studied eye

  10. Numbers of medication

    Time frame: Post-operative on month12th

    Numbers of anti-glaucoma medications

  11. Numbers of medication

    Time frame: Post-operative on month 24th

    Numbers of anti-glaucoma medications

  12. Numbers of medication

    Time frame: Post-operative on month 36th

    Numbers of anti-glaucoma medications

Sponsors and collaborators

Lead sponsor

Siriraj Hospital

Other

Registry information

Official study title

Aflibercept as Adjunctive Treatment for Filtration Surgery in Neovascular

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Jul 21, 2021
Registry last updated
Jul 21, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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