Glaucoma, NeovascularPhase 4NCT01922154
Intravitreous Ranibizumab as Adjunctive Treatment for Trabeculectomy in Neovascular Glaucoma
A Phase 4 study testing intravitreal ranibizumab and Trabeculectomy with mitomycinC in people with Glaucoma, Neovascular, run by Siriraj Hospital at 1 site in Thailand.
Trial summary
To evaluate the effects of intravitreal ranibizumab (IVR) as adjunctive treatment for trabeculectomy with mitomycin C (TMC) in neovascular glaucoma (NVG). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glaucoma, Neovascular
- What is being tested?
- intravitreal ranibizumab and Trabeculectomy with mitomycinC
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteThailand
- Study dates
- Feb 2009to Dec 2012
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Consecutive patients with neovascular glaucoma
- Age more than 80 year old
- Provide written informed consent
Who cannot join
- Un-cooperated patients
Trial locations and contacts
1 site in 1 country.
About this study
To evaluate the effects of intravitreal ranibizumab (IVR) as adjunctive treatment for trabeculectomy with mitomycin C (TMC) in neovascular glaucoma (NVG).
Read the 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.
- Conditions
- Glaucoma, Neovascular
- Being tested
- intravitreal ranibizumab, Trabeculectomy with mitomycinC
- Keywords
- Angiogenesis inhibitors, Neovascular, Intraocular pressure, Retinal Vein Occlusion, Vascular Endothelial Growth Factor
- Medical subject headings
- Glaucoma, Neovascular, Retinal Vein Occlusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intravitreal ranibizumabDrug
Also called Lucentis; Genentech Inc, San Francisco, CA
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.
Trabeculectomy with mitomycinCProcedure or surgery
All participant underwent trabeculectomy with mitomycinC , which is the standard procedure for refractory glaucoma.
| Study group | Role | What they receive |
|---|---|---|
| intravitreal ranibizumab | Experimental | 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. Receives: Drug: intravitreal ranibizumab; Procedure: Trabeculectomy with mitomycinC |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change of intraocular pressure (IOP)
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.
Measured: Change of IOP between before trabeculectomy and at last visit
Secondary outcomes (1)
The safety of intravitreal ranibizumab (IVR)
Blood pressure (mmHg) change
Measured: On the day patient receives IVR
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2013 (estimated)
- Study startFeb 2009
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Glaucoma, NeovascularStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Siriraj Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Naris Kitnarong, Siriraj Hospital
- Investigators
- Naris Kitnarong, M.D., Principal investigator, Mahidol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01922154
- Sponsor's protocol ID
- NK002
- Status last verified
- Jul 2021
- First submitted
- 4 Aug 2013
- Last updated
- 16 Jul 2021
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 18425438Alkawas AA, Shahien EA, Hussein AM. Management of neovascular glaucoma with panretinal photocoagulation, intravitreal bevacizumab, and subsequent trabeculectomy with mitomycin C. J Glaucoma. 2010 Dec;19(9):622-6. doi: 10.1097/IJG.0b013e3181ccb794.
PubMed 20179624Dunavoelgyi R, Zehetmayer M, Simader C, Schmidt-Erfurth U. Rapid improvement of radiation-induced neovascular glaucoma and exudative retinal detachment after a single intravitreal ranibizumab injection. Clin Exp Ophthalmol. 2007 Dec;35(9):878-80. doi: 10.1111/j.1442-9071.2007.01632.x.
PubMed 18173426
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intravitreous Ranibizumab as Adjunctive Treatment for Trabeculectomy in Neovascular Glaucoma
- ClinicalTrials.gov ID
- NCT01922154
- Acronym / sponsor ID
- NK002
- Conditions
- Glaucoma, Neovascular
- Keywords
- Angiogenesis inhibitors, Neovascular, Intraocular pressure, Retinal Vein Occlusion, Vascular Endothelial Growth Factor
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Siriraj HospitalUniversity, hospital or other
- Study start
- Feb 2009
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 14 Aug 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| intravitreal ranibizumab | Experimental | Drug: intravitreal ranibizumab, Procedure: Trabeculectomy with mitomycinCRanibizumab 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Consecutive patients with neovascular glaucoma
- Age more than 80 year old
- Provide written informed consent
Key exclusion criteria (1 listed)
- Un-cooperated patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| intravitreal ranibizumabAlso: Lucentis; Genentech Inc, San Francisco, CAThe 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. | Drug | intravitreal ranibizumab |
| Trabeculectomy with mitomycinCAll participant underwent trabeculectomy with mitomycinC , which is the standard procedure for refractory glaucoma. | Procedure or surgery | intravitreal ranibizumab |
Primary outcome
The change of intraocular pressure (IOP)
Time frame: 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.
1 secondary outcome
The safety of intravitreal ranibizumab (IVR)
Time frame: On the day patient receives IVR
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2021.
- Background: PubMed 18425438Kitnarong 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.
- Background: PubMed 20179624Alkawas AA, Shahien EA, Hussein AM. Management of neovascular glaucoma with panretinal photocoagulation, intravitreal bevacizumab, and subsequent trabeculectomy with mitomycin C. J Glaucoma. 2010 Dec;19(9):622-6. doi: 10.1097/IJG.0b013e3181ccb794.
- Results publication: PubMed 18173426Dunavoelgyi R, Zehetmayer M, Simader C, Schmidt-Erfurth U. Rapid improvement of radiation-induced neovascular glaucoma and exudative retinal detachment after a single intravitreal ranibizumab injection. Clin Exp Ophthalmol. 2007 Dec;35(9):878-80. doi: 10.1111/j.1442-9071.2007.01632.x.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Naris Kitnarong, M.D. principal investigator
Mahidol University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing intravitreal ranibizumab and Trabeculectomy with mitomycinC in people with Glaucoma, Neovascular, run by Siriraj Hospital at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The change of intraocular pressure (IOP) (time frame: Change of IOP between before trabeculectomy and at last visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01922154, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2021.