Intravitreous Ranibizumab as Adjunctive Treatment for Trabeculectomy in Neovascular Glaucoma

Sponsor
Siriraj Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT01922154
Collaborator
(none)
15
1
1
46
0.3

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Drug: intravitreal ranibizumab
  • Procedure: Trabeculectomy with mitomycinC
Phase 4

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
15 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Intravitreous Ranibizumab as Adjunctive Treatment for Trabeculectomy in Neovascular Glaucoma
Study Start Date :
Feb 1, 2009
Actual Primary Completion Date :
Dec 1, 2012
Actual Study Completion Date :
Dec 1, 2012

Arms and Interventions

Arm Intervention/Treatment
Experimental: intravitreal ranibizumab

Ranibizumab was injected into vitreous cavity in the study eye once (0.5 mg/0.05 ml) at least 1 week before performing trabeculectomy with mitomycin C.

Drug: intravitreal ranibizumab
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.
Other Names:
  • Lucentis; Genentech Inc, San Francisco, CA
  • Procedure: Trabeculectomy with mitomycinC
    All participant underwent trabeculectomy with mitomycinC , which is the standard procedure for refractory glaucoma.

    Outcome Measures

    Primary Outcome Measures

    1. The change of intraocular pressure (IOP) [Change of IOP between before trabeculectomy and at last visit]

      The 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 Outcome Measures

    1. The safety of intravitreal ranibizumab (IVR) [On the day patient receives IVR]

      Blood pressure (mmHg) change

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Naris Kitnarong Bangkok Thailand 10700

    Sponsors and Collaborators

    • Siriraj Hospital

    Investigators

    • Principal Investigator: Naris Kitnarong, M.D., Mahidol University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Naris Kitnarong, Associate professor, Siriraj Hospital
    ClinicalTrials.gov Identifier:
    NCT01922154
    Other Study ID Numbers:
    • NK002
    First Posted:
    Aug 14, 2013
    Last Update Posted:
    Jul 16, 2021
    Last Verified:
    Jul 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Keywords provided by Naris Kitnarong, Associate professor, Siriraj Hospital
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jul 16, 2021