Neovascular GlaucomaNCT05156021
A Study on the Treatment Strategy of NVG Secondary to PDR
A study testing anti-VEGF in people with Neovascular Glaucoma and Proliferative Diabetic Retinopathy, run by Ruijin Hospital at 1 site in China.
Trial summary
With the increasing incidence of proliferative diabetic retinopathy (PDR), subsequent neovascular glaucoma (NVG) has become one of the main causes of blindness in PDR patients, and the intraocular pressure of PDR patients with NVG is often stubborn. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neovascular Glaucoma, Proliferative Diabetic Retinopathy
- What is being tested?
- anti-VEGF
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteChina
- Study dates
- 12 Dec 2021to 31 Dec 2022
- 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
- male or female patients aged over 18 years diagnosed with type 1 or 2 diabetic mellitus (DM) confirmed by experienced endocrinologists. Active PDR and NVG was clinically evident across these patients. The indications to perform surgery included vitreous hemorrhage or fibrous proliferation in the macular area, together with uncontrolled intraocular pressure.
Who cannot join
- (i) coexistent ocular disease that may interfere with visual outcome; (ii) previous history of vitrectomy or anti-VEGF pharmacotherapy in either eye; (iii) a macula-involving retinal detachment for >6 months in the study eye; (iv) severe external ocular infection; (v) usage of anticoagulant or antiplatelet therapy; (vi) preoperative or postoperative poor diabetes control [serum hemoglobin A1c (HbA1c) >11.0%]; (vii) uncontrolled systemic diseases, such as hypertension, cardiac diseases or presenting abnormal coagulation-associated blood diseases.
Trial locations and contacts
1 site in 1 country.
China1 site
Ruijin Hospital Affiliated to Shanghai Jiaotong University School of Medicine,
Shanghai
About this study
Official title: A Study on the Treatment Strategy of Neovascular Glaucoma Secondary to Proliferative Diabetic Retinopathy
With the increasing incidence of proliferative diabetic retinopathy (PDR), subsequent neovascular glaucoma (NVG) has become one of the main causes of blindness in PDR patients, and the intraocular pressure of PDR patients with NVG is often stubborn. For these patients, not only is the effect of drugs in lowering intraocular pressure poor, but the results of surgery are often unsatisfactory. Because of its poor prognosis, clinical research for better strategy is of great significance in the current situation. At present, for such patients, a combination of effective control of intraocular pressure and treatment of the primary disease is often used. The purpose of this study was to investigate the clinical effects of preoperative with/without intraoperative anti-vascular endothelial growth factor (VEGF) drug therapy combined with pars plana vitrectomy (PPV), pan-retinal photocoagulation (PRP), and pressure-reducing valve implantation in patients with NVG secondary to PDR. Furthermore, the changes of neurotrophic factors in the vitreous humor before and after anti-VEGF treatment will be explored.
- Being tested
- anti-VEGF
- Medical subject headings
- Glaucoma, Neovascular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
anti-VEGFDrug
To explore whether adding post-vitrectomy anti-VEGF agent injection can reach a better prognosis in PDR patients with NVG who underwent PPV combined with PRP and pressure-reducing valve implantation
| Study group | Role | What they receive |
|---|---|---|
| pre-vitrectomy anti-VEGF injection group | Experimental | Patient in this group receive an intravitreal injection of anti-VEGF drug 3-5 days before surgery, followed by PPV combined with PRP and pressure-reducing valve implantation Receives: Drug: anti-VEGF |
| pre and post-vitrectomy anti-VEGF injection group | Experimental | Patient in this group receive two intravitreal injections of anti-VEGF drugs. One is injected 3-5 days before surgery, the other is at the same time as the PPV combined with PRP and pressure reducing valve implantation is completed. Receives: Drug: anti-VEGF |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Best Corrected Visual Acuity from baseline to 12 months after surgery
Measured: Follow-up on the first day, first week, 1, 3, 6, 9 and 12 months after surgery
Changes in Intraocular Pressure from baseline to 12 months after surgery
Measured: Follow-up on the first day, first week, 1, 3, 6, 9 and 12 months after surgery
Secondary outcomes (2)
Changes in Neovascularization Recurrence Rate from baseline to 12 months after surgery
Measured: Follow-up on the first day, first week, 1, 3, 6, 9 and 12 months after surgery
Changes in Ocular and Systemic Adverse Events from baseline to 12 months after surgery
Measured: Follow-up on the first day, first week, 1, 3, 6, 9 and 12 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2021
- Study start12 Dec 2021
- Primary completion31 Dec 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neovascular GlaucomaStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xi Shen, Principal investigator, Ruijin Hospital, Affiliated Shanghai Jiaotong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05156021
- Sponsor's protocol ID
- RuijinHospital
- Status last verified
- Oct 2021
- First submitted
- 14 Oct 2021
- Last updated
- 21 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study on the Treatment Strategy of Neovascular Glaucoma Secondary to Proliferative Diabetic Retinopathy
- ClinicalTrials.gov ID
- NCT05156021
- Acronym / sponsor ID
- RuijinHospital
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Study start
- 12 Dec 2021 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 14 Dec 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.
With the increasing incidence of proliferative diabetic retinopathy (PDR), subsequent neovascular glaucoma (NVG) has become one of the main causes of blindness in PDR patients, and the intraocular pressure of PDR patients with NVG is often stubborn. For these patients, not only is the effect of drugs in lowering intraocular pressure poor, but the results of surgery are often unsatisfactory. Because of its poor prognosis, clinical research for better strategy is of great significance in the current situation. At present, for such patients, a combination of effective control of intraocular pressure and treatment of the primary disease is often used. The purpose of this study was to investigate the clinical effects of preoperative with/without intraoperative anti-vascular endothelial growth factor (VEGF) drug therapy combined with pars plana vitrectomy (PPV), pan-retinal photocoagulation (PRP), and pressure-reducing valve implantation in patients with NVG secondary to PDR. Furthermore, the changes of neurotrophic factors in the vitreous humor before and after anti-VEGF treatment will be explored.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| pre-vitrectomy anti-VEGF injection group | Experimental | Drug: anti-VEGFPatient in this group receive an intravitreal injection of anti-VEGF drug 3-5 days before surgery, followed by PPV combined with PRP and pressure-reducing valve implantation |
| pre and post-vitrectomy anti-VEGF injection group | Experimental | Drug: anti-VEGFPatient in this group receive two intravitreal injections of anti-VEGF drugs. One is injected 3-5 days before surgery, the other is at the same time as the PPV combined with PRP and pressure reducing valve implantation is completed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- male or female patients aged over 18 years diagnosed with type 1 or 2 diabetic mellitus (DM) confirmed by experienced endocrinologists. Active PDR and NVG was clinically evident across these patients. The indications to perform surgery included vitreous hemorrhage or fibrous proliferation in the macular area, together with uncontrolled intraocular pressure.
Key exclusion criteria (1 listed)
- (i) coexistent ocular disease that may interfere with visual outcome; (ii) previous history of vitrectomy or anti-VEGF pharmacotherapy in either eye; (iii) a macula-involving retinal detachment for >6 months in the study eye; (iv) severe external ocular infection; (v) usage of anticoagulant or antiplatelet therapy; (vi) preoperative or postoperative poor diabetes control [serum hemoglobin A1c (HbA1c) >11.0%]; (vii) uncontrolled systemic diseases, such as hypertension, cardiac diseases or presenting abnormal coagulation-associated blood diseases.
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 |
|---|---|---|
| anti-VEGFTo explore whether adding post-vitrectomy anti-VEGF agent injection can reach a better prognosis in PDR patients with NVG who underwent PPV combined with PRP and pressure-reducing valve implantation | Drug | pre and post-vitrectomy anti-VEGF injection group, pre-vitrectomy anti-VEGF injection group |
Primary outcome
Changes in Best Corrected Visual Acuity from baseline to 12 months after surgery
Time frame: Follow-up on the first day, first week, 1, 3, 6, 9 and 12 months after surgery
Changes in Intraocular Pressure from baseline to 12 months after surgery
Time frame: Follow-up on the first day, first week, 1, 3, 6, 9 and 12 months after surgery
2 secondary outcomes
Changes in Neovascularization Recurrence Rate from baseline to 12 months after surgery
Time frame: Follow-up on the first day, first week, 1, 3, 6, 9 and 12 months after surgery
Changes in Ocular and Systemic Adverse Events from baseline to 12 months after surgery
Time frame: Follow-up on the first day, first week, 1, 3, 6, 9 and 12 months after surgery
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 Aug 2023.
- 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.
Xi Shen principal investigator
Ruijin Hospital, Affiliated Shanghai Jiaotong University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing anti-VEGF in people with Neovascular Glaucoma and Proliferative Diabetic Retinopathy, run by Ruijin Hospital at 1 site in China.
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 1 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 Aug 2023. 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 China. 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?
Changes in Best Corrected Visual Acuity from baseline to 12 months after surgery (time frame: Follow-up on the first day, first week, 1, 3, 6, 9 and 12 months after surgery). 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?
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 Aug 2023.