Clinical trial NCT04970251: Aflibercept as Adjunctive Treatment for Filtration Surgery in Neovascular Glaucoma
Official title: Aflibercept as Adjunctive Treatment for Filtration Surgery in Neovascular
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intraocular Pressure
Neovascular Glaucoma
Vascular Endothelial Growth Factor Overexpression
Glaucoma Secondary to Eye Inflammation
Lead sponsor: Siriraj Hospital
Sponsor class: OTHER
First posted: 2021-07-21
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Intraocular pressure
timeFrame: Post-operative on day 1st
measure: Intraocular pressure
timeFrame: Post-operative on day 7th
measure: Intraocular pressure
timeFrame: Post-operative on month 3rd
measure: Intraocular pressure
timeFrame: Post-operative on month 6th
measure: Intraocular pressure
timeFrame: Post-operative on month 12th
measure: Intraocular pressure
timeFrame: Post-operative on month 18th
measure: Intraocular pressure
timeFrame: Post-operative on month 24th
measure: Intraocular pressure
timeFrame: Post-operative on month 30th
measure: Intraocular pressure
timeFrame: Post-operative on month 36th
Secondary outcomes:
measure: Visual acuity
timeFrame: Post-operative on day 1st
measure: Visual acuity
timeFrame: Post-operative on day 7th
measure: Visual acuity
timeFrame: Post-operative on month 3rd
measure: Visual acuity
timeFrame: Post-operative on month 6th
measure: Visual acuity
timeFrame: Post-operative on month 12th
measure: Visual acuity
timeFrame: Post-operative on month 18th
measure: Visual acuity
timeFrame: Post-operative on month 24th
measure: Visual acuity
timeFrame: Post-operative on month 30th
measure: Visual acuity
timeFrame: Post-operative on month 36th
measure: Numbers of medication
timeFrame: Post-operative on month12th
measure: Numbers of medication
timeFrame: Post-operative on month 24th
measure: Numbers of medication
timeFrame: Post-operative on month 36th
Other outcomes:
Locations:
city: Bangkoknoi
country: Thailand
facility: Naris Kitnarong
state: Bangkok
Study officials:
References:
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.
citation: 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.
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.0000000000000211.