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Intravitreous Ranibizumab as Adjunctive Treatment for Trabeculectomy in Neovascular Glaucoma

Intravitreous Ranibizumab as Adjunctive Treatment for Trabeculectomy in Neovascular Glaucoma

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01922154
Enrollment
15
Registered
2013-08-14
Start date
2009-02-28
Completion date
2012-12-31
Last updated
2021-07-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Glaucoma, Neovascular

Keywords

Angiogenesis inhibitors, Neovascular, Intraocular pressure, Retinal Vein Occlusion, Vascular Endothelial Growth Factor

Brief summary

To evaluate the effects of intravitreal ranibizumab (IVR) as adjunctive treatment for trabeculectomy with mitomycin C (TMC) in neovascular glaucoma (NVG).

Detailed description

This is a prospective study of 15 consecutive eyes from 14 patients (One patients had NVG in both eyes at presentation.) with NVG presented at the Department of Ophthalmology, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand between December 2008 and December 2009. Each eye received IVR (0.5 mg/0.05 ml) 1 week before TMC. Trabeculectomy was performed with fornix-based conjunctival flap method.

Interventions

The patients received IVR (0.5 mg in 0.05 ml) injection through the pars plana in the operating room. A fornix-based conjunctival flap technique trabeculectomy with intraoperative mitomycin C was performed within 2 weeks after IVR.

PROCEDURETrabeculectomy with mitomycinC

All participant underwent trabeculectomy with mitomycinC , which is the standard procedure for refractory glaucoma.

Sponsors

Siriraj Hospital
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Consecutive patients with neovascular glaucoma * Age more than 80 year old * Provide written informed consent

Exclusion criteria

* Un-cooperated patients

Design outcomes

Primary

MeasureTime frameDescription
The change of intraocular pressure (IOP)Change of IOP between before trabeculectomy and at last visitThe change of intraocular pressure (IOP)between before trabeculectomy with mitomycin C (TMC) and after TMC. We compared this change at several time points such as at 6, 12 months and at last visit. The most important is the change of IOP between before TMC and at last visit as well as the level of IOP at last visit which is at of the longest follow-up time.

Secondary

MeasureTime frameDescription
The safety of intravitreal ranibizumab (IVR)On the day patient receives IVRBlood pressure (mmHg) change

Countries

Thailand

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026