Intraocular PressureNCT04970251
Aflibercept as Adjunctive Treatment for Filtration Surgery in Neovascular Glaucoma
A study testing Aflibercept Ophthalmic in people with Intraocular Pressure and Neovascular Glaucoma, run by Siriraj Hospital at 1 site in Thailand.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intraocular Pressure, Neovascular Glaucoma, Vascular Endothelial Growth Factor Overexpression
- What is being tested?
- Aflibercept Ophthalmic
- Type of treatment
- Injection or infusion
- How many people
- 5 participants
- Where
- 1 siteThailand
- Study dates
- 1 Nov 2018to 31 Mar 2021
- Phase
- Interventional
- 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 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
Who cannot join
- Patients who received any anti-vascular endothelial growth factor treatment before participation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Aflibercept as Adjunctive Treatment for Filtration Surgery in Neovascular
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.
- Conditions
- Intraocular Pressure, Neovascular Glaucoma, Vascular Endothelial Growth Factor Overexpression, Glaucoma Secondary to Eye Inflammation
- Being tested
- Aflibercept Ophthalmic
- Medical subject headings
- Glaucoma, Neovascular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aflibercept OphthalmicDrug
Also called trabeculectomy, Panretinal photocoagulation
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraocular pressure
Intraocular pressure after trabeculectomy
Measured: Post-operative on day 1st
Intraocular pressure
Intraocular pressure after trabeculectomy
Measured: Post-operative on day 7th
Intraocular pressure
Intraocular pressure after trabeculectomy
Measured: Post-operative on month 3rd
Intraocular pressure
Intraocular pressure after trabeculectomy
Measured: Post-operative on month 6th
Intraocular pressure
Intraocular pressure after trabeculectomy
Measured: Post-operative on month 12th
Intraocular pressure
Intraocular pressure after trabeculectomy
Measured: Post-operative on month 18th
Intraocular pressure
Intraocular pressure after trabeculectomy
Measured: Post-operative on month 24th
Intraocular pressure
Intraocular pressure after trabeculectomy
Measured: Post-operative on month 30th
Intraocular pressure
Intraocular pressure after trabeculectomy
Measured: Post-operative on month 36th
Secondary outcomes (12)
Visual acuity
Visual acuity of the studied eye
Measured: Post-operative on day 1st
Visual acuity
Visual acuity of the studied eye
Measured: Post-operative on day 7th
Visual acuity
Visual acuity of the studied eye
Measured: Post-operative on month 3rd
Visual acuity
Visual acuity of the studied eye
Measured: Post-operative on month 6th
Visual acuity
Visual acuity of the studied eye
Measured: Post-operative on month 12th
Visual acuity
Visual acuity of the studied eye
Measured: Post-operative on month 18th
Visual acuity
Visual acuity of the studied eye
Measured: Post-operative on month 24th
Visual acuity
Visual acuity of the studied eye
Measured: Post-operative on month 30th
Visual acuity
Visual acuity of the studied eye
Measured: Post-operative on month 36th
Numbers of medication
Numbers of anti-glaucoma medications
Measured: Post-operative on month12th
Numbers of medication
Numbers of anti-glaucoma medications
Measured: Post-operative on month 24th
Numbers of medication
Numbers of anti-glaucoma medications
Measured: Post-operative on month 36th
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2021
- Study start1 Nov 2018
- Primary completion31 Mar 2021
- Study completion31 Mar 2021
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 Intraocular PressureStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Siriraj Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Naris Kitnarong, Siriraj Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04970251
- Sponsor's protocol ID
- Si726/2018
- Status last verified
- Jul 2021
- First submitted
- 24 Jun 2021
- Last updated
- 21 Jul 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Centers who collect the data of neovascular Glaucoma patients who underwent intravitreal aflibercept injection, pan retinal photocoagulation and trabeculectomy with mitomycin C.
Publications
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.
PubMed 25812531Kitnarong 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 18425438Kobayashi 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.
PubMed 25580888
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aflibercept as Adjunctive Treatment for Filtration Surgery in Neovascular
- ClinicalTrials.gov ID
- NCT04970251
- Acronym / sponsor ID
- Si726/2018
- Conditions
- Intraocular Pressure, Neovascular Glaucoma, Vascular Endothelial Growth Factor Overexpression, Glaucoma Secondary to Eye Inflammation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Siriraj HospitalUniversity, hospital or other
- Study start
- 1 Nov 2018 (actual)
- Primary completion
- 31 Mar 2021 (actual)
- Study completion
- 31 Mar 2021 (actual)
- First posted
- 21 Jul 2021 (actual)
- 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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- Patients who received any anti-vascular endothelial growth factor treatment before participation
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 |
|---|---|---|
| Aflibercept OphthalmicAlso: trabeculectomy, Panretinal photocoagulationPanretinal 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. | Drug | – |
Primary outcome
Intraocular pressure
Time frame: Post-operative on day 1st
Intraocular pressure after trabeculectomy
Intraocular pressure
Time frame: Post-operative on day 7th
Intraocular pressure after trabeculectomy
Intraocular pressure
Time frame: Post-operative on month 3rd
Intraocular pressure after trabeculectomy
Intraocular pressure
Time frame: Post-operative on month 6th
Intraocular pressure after trabeculectomy
Intraocular pressure
Time frame: Post-operative on month 12th
Intraocular pressure after trabeculectomy
Intraocular pressure
Time frame: Post-operative on month 18th
Intraocular pressure after trabeculectomy
Intraocular pressure
Time frame: Post-operative on month 24th
Intraocular pressure after trabeculectomy
Intraocular pressure
Time frame: Post-operative on month 30th
Intraocular pressure after trabeculectomy
Intraocular pressure
Time frame: Post-operative on month 36th
Intraocular pressure after trabeculectomy
12 secondary outcomes
Visual acuity
Time frame: Post-operative on day 1st
Visual acuity
Time frame: Post-operative on day 7th
Visual acuity
Time frame: Post-operative on month 3rd
Visual acuity
Time frame: Post-operative on month 6th
Visual acuity
Time frame: Post-operative on month 12th
Visual acuity
Time frame: Post-operative on month 18th
Visual acuity
Time frame: Post-operative on month 24th
Visual acuity
Time frame: Post-operative on month 30th
Visual acuity
Time frame: Post-operative on month 36th
Numbers of medication
Time frame: Post-operative on month12th
Numbers of medication
Time frame: Post-operative on month 24th
Numbers of medication
Time frame: Post-operative on month 36th
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 21 Jul 2021.
- Results publication: PubMed 25812531Kitnarong 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.
- Results publication: 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.
- Results publication: PubMed 25580888Kobayashi 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.
- Individual participant dataSharing planned: Undecided. Centers who collect the data of neovascular Glaucoma patients who underwent intravitreal aflibercept injection, pan retinal photocoagulation and trabeculectomy with mitomycin C.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aflibercept Ophthalmic in people with Intraocular Pressure and Neovascular Glaucoma, 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 2 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 21 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.
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?
Intraocular pressure (time frame: Post-operative on day 1st). The study lists 9 primary outcomes in all. 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 NCT04970251, 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 21 Jul 2021.