Aflibercept as Adjunctive Treatment for Filtration Surgery in Neovascular Glaucoma

Intraocular Pressure Clinical Trial

Official title:

Aflibercept as Adjunctive Treatment for Filtration Surgery in Neovascular

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04970251
• Other study ID #: Si726/2018
• Status: Completed
• Phase: N/A
• Start date: November 1, 2018
• Est. completion date: March 31, 2021

Study information

• Verified date: July 2021
• Source: Siriraj Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5
• Est. completion date: March 31, 2021
• Est. primary completion date: March 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Glaucoma
• Glaucoma, Neovascular
• Inflammation
• Intraocular Pressure
• Neovascular Glaucoma
• Vascular Endothelial Growth Factor Overexpression

Intervention

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.

Locations

Country	Name	City	State
Thailand	Naris Kitnarong	Bangkoknoi	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Siriraj Hospital

Country where clinical trial is conducted

Thailand, 

References & Publications (3)

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. — View 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 — View 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.00000000000 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intraocular pressure	Intraocular pressure after trabeculectomy	Post-operative on day 1st
Primary	Intraocular pressure	Intraocular pressure after trabeculectomy	Post-operative on day 7th
Primary	Intraocular pressure	Intraocular pressure after trabeculectomy	Post-operative on month 3rd
Primary	Intraocular pressure	Intraocular pressure after trabeculectomy	Post-operative on month 6th
Primary	Intraocular pressure	Intraocular pressure after trabeculectomy	Post-operative on month 12th
Primary	Intraocular pressure	Intraocular pressure after trabeculectomy	Post-operative on month 18th
Primary	Intraocular pressure	Intraocular pressure after trabeculectomy	Post-operative on month 24th
Primary	Intraocular pressure	Intraocular pressure after trabeculectomy	Post-operative on month 30th
Primary	Intraocular pressure	Intraocular pressure after trabeculectomy	Post-operative on month 36th
Secondary	Visual acuity	Visual acuity of the studied eye	Post-operative on day 1st
Secondary	Visual acuity	Visual acuity of the studied eye	Post-operative on day 7th
Secondary	Visual acuity	Visual acuity of the studied eye	Post-operative on month 3rd
Secondary	Visual acuity	Visual acuity of the studied eye	Post-operative on month 6th
Secondary	Visual acuity	Visual acuity of the studied eye	Post-operative on month 12th
Secondary	Visual acuity	Visual acuity of the studied eye	Post-operative on month 18th
Secondary	Visual acuity	Visual acuity of the studied eye	Post-operative on month 24th
Secondary	Visual acuity	Visual acuity of the studied eye	Post-operative on month 30th
Secondary	Visual acuity	Visual acuity of the studied eye	Post-operative on month 36th
Secondary	Numbers of medication	Numbers of anti-glaucoma medications	Post-operative on month12th
Secondary	Numbers of medication	Numbers of anti-glaucoma medications	Post-operative on month 24th
Secondary	Numbers of medication	Numbers of anti-glaucoma medications	Post-operative on month 36th