Diabetic RetinopathyPhase 4NCT02647515
Intravitreal Ranibizumab Injection as Adjuvant in the Treatment of Postvitrectomy Diabetic Vitreous Hemorrhage Accompanied by Neovascular Glaucoma
A Phase 4 study testing ranibizumab in people with Diabetic Retinopathy and Glaucoma, Neovascular, run by Ruijin Hospital.
Trial summary
To determine the efficacy of intravitreal ranibizumab injection as adjuvant therapy in the treatment of postvitrectomy diabetic vitreous hemorrhage (PDVH) accompanied by neovascular glaucoma (NVG) as a means of preventing recurrent vitreous hemorrhage （VH） and optimizing postoperative intraocular pressure（IOP）control. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Retinopathy, Glaucoma, Neovascular
- What is being tested?
- ranibizumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- No sites listed yet
- Study dates
- Jan 2013to Dec 2014
- 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
- age≥18 years
- PDVH obscuring the disc and vessels for more than 14 days and no evidence of retinal detachment after primary vitrectomy for PDR-related complications such as nonclearing VH, macula-involving or macula-threatening tractional retinal detachment, or fibrovascular proliferation with vitreoretinal adhesions
- NVG occurred following PDVH less than 4 weeks (NVG was diagnosed when an IOP elevation of 22mmHg or more was accompanied by neovascularization of the iris and/or the anterior chamber angle)
Who cannot join
- intraoperative use of long-acting gas or silicone oil in primary vitrectomy, repeat vitrectomy after primary vitrectomy for retinal diseases other than VH, previous history of vitrectomy
- previous intravitreal injection of ranibizumab or bevacizumab in either eye
- previous intravitreal corticosteroids injection in either eye
- pregnancy or current oral contraceptive intake
- usage of clopidogrel bisulfate or coumadin
- uncontrolled hypertension and cardiac disease
- uncontrolled renal or liver disease
About this study
To determine the efficacy of intravitreal ranibizumab injection as adjuvant therapy in the treatment of postvitrectomy diabetic vitreous hemorrhage (PDVH) accompanied by neovascular glaucoma (NVG) as a means of preventing recurrent vitreous hemorrhage （VH） and optimizing postoperative intraocular pressure（IOP）control.
- Conditions
- Diabetic Retinopathy, Glaucoma, Neovascular
- Being tested
- ranibizumab
- Medical subject headings
- Diabetic Retinopathy, Glaucoma, Neovascular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ranibizumabDrug
| Study group | Role | What they receive |
|---|---|---|
| ranibizumab | Experimental | Not described Receives: Drug: ranibizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
vitreous hemorrhage
Measured: 12 months
intraocular pressure
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2016 (estimated)
- Study startJan 2013
- Primary completionDec 2014
- Study completionDec 2014
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 Diabetic RetinopathyStudies of the same condition, open and under way.
- More trials run by Ruijin HospitalThe sponsor's other registered studies.
- 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
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Ningbo University
- Responsible party
- Principal investigator, Xi Shen, Ruijin Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02647515
- Sponsor's protocol ID
- XShen
- Status last verified
- Jan 2013
- First submitted
- 30 Dec 2015
- Last updated
- 6 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes
Publications
Schachat AP, Oyakawa RT, Michels RG, Rice TA. Complications of vitreous surgery for diabetic retinopathy. II. Postoperative complications. Ophthalmology. 1983 May;90(5):522-30. doi: 10.1016/s0161-6420(83)34540-1.
PubMed 6192378Luke J, Nassar K, Luke M, Grisanti S. Ranibizumab as adjuvant in the treatment of rubeosis iridis and neovascular glaucoma--results from a prospective interventional case series. Graefes Arch Clin Exp Ophthalmol. 2013 Oct;251(10):2403-13. doi: 10.1007/s00417-013-2428-y. Epub 2013 Jul 28.
PubMed 23893090Shen X, Chen Y, Wang Y, Yang L, Zhong Y. Intravitreal Ranibizumab Injection as an Adjuvant in the Treatment of Neovascular Glaucoma Accompanied by Vitreous Hemorrhage after Diabetic Vitrectomy. J Ophthalmol. 2016;2016:4108490. doi: 10.1155/2016/4108490. Epub 2016 May 16.
PubMed 27293875
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intravitreal Ranibizumab Injection as Adjuvant in the Treatment of Postvitrectomy Diabetic Vitreous Hemorrhage Accompanied by Neovascular Glaucoma
- ClinicalTrials.gov ID
- NCT02647515
- Acronym / sponsor ID
- XShen
- Conditions
- Diabetic Retinopathy, Glaucoma, Neovascular
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Collaborators
- Ningbo University
- Study start
- Jan 2013
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 6 Jan 2016 (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 determine the efficacy of intravitreal ranibizumab injection as adjuvant therapy in the treatment of postvitrectomy diabetic vitreous hemorrhage (PDVH) accompanied by neovascular glaucoma (NVG) as a means of preventing recurrent vitreous hemorrhage （VH） and optimizing postoperative intraocular pressure（IOP）control.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ranibizumab | Experimental | Drug: ranibizumab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- age≥18 years
- PDVH obscuring the disc and vessels for more than 14 days and no evidence of retinal detachment after primary vitrectomy for PDR-related complications such as nonclearing VH, macula-involving or macula-threatening tractional retinal detachment, or fibrovascular proliferation with vitreoretinal adhesions
- NVG occurred following PDVH less than 4 weeks (NVG was diagnosed when an IOP elevation of 22mmHg or more was accompanied by neovascularization of the iris and/or the anterior chamber angle)
Key exclusion criteria (7 listed)
- intraoperative use of long-acting gas or silicone oil in primary vitrectomy, repeat vitrectomy after primary vitrectomy for retinal diseases other than VH, previous history of vitrectomy
- previous intravitreal injection of ranibizumab or bevacizumab in either eye
- previous intravitreal corticosteroids injection in either eye
- pregnancy or current oral contraceptive intake
- usage of clopidogrel bisulfate or coumadin
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 |
|---|---|---|
| ranibizumab | Drug | ranibizumab |
Primary outcome
vitreous hemorrhage
Time frame: 12 months
intraocular pressure
Time frame: 12 months
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 6 Jan 2016.
- Background: PubMed 6192378Schachat AP, Oyakawa RT, Michels RG, Rice TA. Complications of vitreous surgery for diabetic retinopathy. II. Postoperative complications. Ophthalmology. 1983 May;90(5):522-30. doi: 10.1016/s0161-6420(83)34540-1.
- Background: PubMed 23893090Luke J, Nassar K, Luke M, Grisanti S. Ranibizumab as adjuvant in the treatment of rubeosis iridis and neovascular glaucoma--results from a prospective interventional case series. Graefes Arch Clin Exp Ophthalmol. 2013 Oct;251(10):2403-13. doi: 10.1007/s00417-013-2428-y. Epub 2013 Jul 28.
- Derived from this study: PubMed 27293875Shen X, Chen Y, Wang Y, Yang L, Zhong Y. Intravitreal Ranibizumab Injection as an Adjuvant in the Treatment of Neovascular Glaucoma Accompanied by Vitreous Hemorrhage after Diabetic Vitrectomy. J Ophthalmol. 2016;2016:4108490. doi: 10.1155/2016/4108490. Epub 2016 May 16.
- Individual participant dataSharing planned: Yes
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing ranibizumab in people with Diabetic Retinopathy and Glaucoma, Neovascular, run by Ruijin Hospital.
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 7 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 6 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
vitreous hemorrhage (time frame: 12 months). The study lists 2 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 NCT02647515, 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 6 Jan 2016.