Aflibercept as Adjunctive Treatment for Filtration Surgery in Neovascular Glaucoma

Overview

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.

Full Title of Study: “Aflibercept as Adjunctive Treatment for Filtration Surgery in Neovascular”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: March 31, 2021

Interventions

  • Drug: Aflibercept Ophthalmic
    • 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.

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Siriraj Hospital
  • Provider of Information About this Clinical Study
    • Principal Investigator: Naris Kitnarong, Associate professor – Siriraj Hospital

Citations Reporting on Results

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.

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.

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.

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.