Diabetic RetinopathyPhase 1NCT05248334
A Prospective Study of Ranibizumab in the Treatment of Postoperative Recurrent Vitreous Haemorrhage of Diabetic Retinopathy
A Phase 1 study testing Ranibizumab Injection and PPV in people with Diabetic Retinopathy and Postoperative Recurrent Vitreous Hemorrhage, run by Tianjin Medical University Eye Hospital at 1 site in China.
Trial summary
Diabetic retinopathy (DR) is one of the main complications in diabetes, the proliferative diabetic retinopathy (PDR) is the most important one of the reasons leading to decreased vision, PDR is the stage of clinical intervention. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Diabetic Retinopathy, Postoperative Recurrent Vitreous Hemorrhage, Pars Plana Vitrectomy
- What is being tested?
- Ranibizumab Injection and PPV
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 10 Apr 2022to 30 Dec 2024
- Phase
- Phase 1
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Voluntary and able to sign an informed consent form
- Age ≥18 years
- Documented diagnosis of diabetes mellitus (type I or type II diabetes) as defined by the American Diabetes Association or World Health Organization criteria and glycosylated hemoglobin ≤10% within 2 months
- Willing and able to complete all planned visits and evaluations
- Complete Panretinal photocoagulation
- Retinal repositioning
- Complete postoperative vitreous hemorrhage clearance for more than 1 week and non-absorption of recurrent vitreous hemorrhage for more than 4 weeks (grade 2 and above)
- Early postoperative period (1 week to 1 month postoperatively) and delayed postoperative period (4 weeks to 12 months postoperatively)
Who cannot join
- Patients with less than 6 months of follow-up
- Silicone oil filling
- Other retinal causes of vitreous hemorrhage
- Tractive retinal detachment, pre-retinal proliferative membrane
- Iris redness, neovascular glaucoma
- History of glaucoma
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- Ocular inflammation
- Any other intraocular surgery (e.g., corneal transplantation, glaucoma filtration, corneal transplantation therapy, etc.)
- Patients with best corrected visual acuity manual or worse, patients with a single eye
- Previous cerebrovascular or thromboembolic events, hypertensive disorders, renal disease, current use of anticoagulants
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Tianjin medical university eye hosipital
Tianjin, Tianjin Municipality
Bojie Hu, 13612130943, bhu07@tmu.edu.cn
About this study
Official title: Ranibizumab in the Treatment of Postoperative Recurrent Vitreous Haemorrhage of Diabetic Retinopathy
Diabetic retinopathy (DR) is one of the main complications in diabetes, the proliferative diabetic retinopathy (PDR) is the most important one of the reasons leading to decreased vision, PDR is the stage of clinical intervention. Pars plana vitrectomy (PPV) is an effective treatment for PDR, while vitreous haemorrhage (VH) is a common complication after PPV, with incidence ranging from 11.8% to 75%, and is the main cause of reoperation. Anti-Vascular endothelial growth factor (VEGF) therapy for vitreous hemorrhage can inhibit neovascularization and prevent recurrent vitreous haemorrhage after absorption. Previous studies have found that anti-VEGF is a safe and effective treatment for postoperative recurrent VH. In consideration of the psychological and economic factor of patients, this study intends to observe the effectiveness of single vitreous injection of Ranibizumab in the treatment of postoperative recurrent VH on the basis of previous clinical work. Compare the visual acuity, macular thickness, VH recurrence and patient satisfaction between the Ranibizumab group and the PPV group by randomized grouping.To observe the effective rate and clearance time of recurrent VH after Ranibizumab treatment and whether it can effectively reduce the rate of PPV. To provide clinical guidance for the precise treatment of PDR patients, the treatment of PDR patients has important clinical significance and social and economic significance.
Read the detailed description
- Patients with proliferative diabetic retinopathy who underwent vitrectomy were collected. Vitreous hemorrhage was completely cleared for more than 1 week after surgery, and vitreous recurrent hemorrhage was not absorbed for more than 4 weeks (grade 2 and above). If the patient has recurrent vitreous hemorrhage or symptoms suggestive of recurrent vitreous hemorrhage, ultrasound at 10mhz posterior segment and 20mhz anterior segment are performed by an experienced sonographer. Patients were randomly assigned to PPV group or Ranibizumab group according to the order in which they came to visit and according to a random number table.
- PPV group: PPV and pan retinal photocoagulation; in the Ranibizumab group, Ranibizumab was injected and pan retinal photocoagulation was performed during ocular fundus could observed, and observation for 4 weeks. If vitreous hemorrhage was not absorbed/vitreous hemorrhage aggravation/proliferation membrane formation/ retinal detachment, PPV was performed.
- Collected information: best corrected visual acuity, slit lamp and fundus examination, intraocular pressure, B-ultrasound, macular thickness, the date of recurrent vitreous hemorrhage and treatment, vitreous cleaning time, the time of significant improvement of visual acuity, times and duration of vitreous hemorrhage. The follow-up time was 1 day, 2 weeks, 1 month, 2 months, 4 months and 6 months, respectively. To observe the effectiveness of Ranibizumab in the treatment of postoperative recurrent vitreous hemorrhage and reduce the number of vitrectomy.
- Conditions
- Diabetic Retinopathy, Postoperative Recurrent Vitreous Hemorrhage, Pars Plana Vitrectomy, Ranibizumab
- Being tested
- Ranibizumab Injection, PPV
- Medical subject headings
- Diabetic Retinopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ranibizumab InjectionDrug
Also called Panretinal photocoagulation
The Ranibizumab group was treated with one intravitreal injection of 0.5 mg/0.05 ml ranibizumab (Lucentis, Basel, Novartis) at baseline. While additional panretinal photocoagulation was performed if there was sufficient space and view to fill in the previously untreated areas, if needed. Repeated injections will be given after 4 weeks when the clearing of VH was incomplete (for a maximum of two injections).
If vitreous hemorrhage was not absorbed/vitreous hemorrhage aggravation/proliferation membrane formation/retinal detachment after 4 weeks of observation, the treatment was considered failed and PPV was performed.
PPVProcedure or surgery
Also called Panretinal photocoagulation
Vitrectomy to remove vitreous hemorrhage and take additional panretinal photocoagulation. If vitreous hemorrhage was not absorbed/vitreous hemorrhage aggravation/proliferation membrane formation/tractive retinal detachment after 4 weeks of observation, the treatment was considered failed and PPV was performed.
| Study group | Role | What they receive |
|---|---|---|
| Ranibizumab group | Experimental | The Ranibizumab group was treated with one intravitreal injection of 0.5 mg/0.05 ml ranibizumab (Lucentis, Basel, Novartis) at baseline. While additional panretinal photocoagulation was performed if there was sufficient space and view to fill in the previously untreated areas, if needed. Repeated injections will be given after 4 weeks when the clearing of VH was incomplete (for a maximum of two injections).
If vitreous hemorrhage was not absorbed/vitreous hemorrhage aggravation/proliferation membrane formation/retinal detachment after 4 weeks of observation, the treatment was considered failed and PPV was performed. Receives: Drug: Ranibizumab Injection |
| PPV group | Active comparator | Vitrectomy to remove vitreous hemorrhage and take additional panretinal photocoagulation. If vitreous hemorrhage was not absorbed/vitreous hemorrhage aggravation/proliferation membrane formation/tractive retinal detachment after 4 weeks of observation, the treatment was considered failed and PPV was performed. Receives: Procedure: PPV |
What is being measured
The primary outcome is the main question the study is designed to answer.
The cleaning time of postoperative recurrent vitreous hemorrhage
Record VH by B scan and funds examination
Measured: two months
Visual acuity
ETDRS Alphabet Chart
Measured: six moths
Secondary outcomes (3)
Macular thickness
optical coherence tomography (OCT); TOPCON 3D-OCT-2000; Topcon Corporation, Tokyo, Japan
Measured: six moths
Vitreous hemorrhage recurrence
B scan and funds examination
Measured: six moths
The number of pars plana vitrectomy
Record the number of pars plana vitrectomy
Measured: six moths
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2022
- Study start10 Apr 2022
- Primary completion30 Dec 2024 (estimated)
- Study completion30 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic RetinopathyStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tianjin Medical University Eye Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Hebei Provincial Eye Hospital, Cangzhou Eye Hospital
- Responsible party
- Principal investigator, Bojie Hu, Tianjin Medical University Eye Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05248334
- Sponsor's protocol ID
- TianjinMUEHhbj123
- Status last verified
- Feb 2022
- First submitted
- 7 Feb 2022
- Last updated
- 12 Aug 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ranibizumab in the Treatment of Postoperative Recurrent Vitreous Haemorrhage of Diabetic Retinopathy
- ClinicalTrials.gov ID
- NCT05248334
- Acronym / sponsor ID
- TianjinMUEHhbj123
- Conditions
- Diabetic Retinopathy, Postoperative Recurrent Vitreous Hemorrhage, Pars Plana Vitrectomy, Ranibizumab
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Tianjin Medical University Eye HospitalUniversity, hospital or other
- Collaborators
- Hebei Provincial Eye Hospital, Cangzhou Eye Hospital
- Study start
- 10 Apr 2022 (actual)
- Primary completion
- 30 Dec 2024 (estimated)
- Study completion
- 30 Dec 2024 (estimated)
- First posted
- 21 Feb 2022 (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.
Diabetic retinopathy (DR) is one of the main complications in diabetes, the proliferative diabetic retinopathy (PDR) is the most important one of the reasons leading to decreased vision, PDR is the stage of clinical intervention. Pars plana vitrectomy (PPV) is an effective treatment for PDR, while vitreous haemorrhage (VH) is a common complication after PPV, with incidence ranging from 11.8% to 75%, and is the main cause of reoperation. Anti-Vascular endothelial growth factor (VEGF) therapy for vitreous hemorrhage can inhibit neovascularization and prevent recurrent vitreous haemorrhage after absorption. Previous studies have found that anti-VEGF is a safe and effective treatment for postoperative recurrent VH. In consideration of the psychological and economic factor of patients, this study intends to observe the effectiveness of single vitreous injection of Ranibizumab in the treatment of postoperative recurrent VH on the basis of previous clinical work. Compare the visual acuity, macular thickness, VH recurrence and patient satisfaction between the Ranibizumab group and the PPV group by randomized grouping.To observe the effective rate and clearance time of recurrent VH after Ranibizumab treatment and whether it can effectively reduce the rate of PPV. To provide clinical guidance for the precise treatment of PDR patients, the treatment of PDR patients has important clinical significance and social and economic significance.
Detailed description
- Patients with proliferative diabetic retinopathy who underwent vitrectomy were collected. Vitreous hemorrhage was completely cleared for more than 1 week after surgery, and vitreous recurrent hemorrhage was not absorbed for more than 4 weeks (grade 2 and above). If the patient has recurrent vitreous hemorrhage or symptoms suggestive of recurrent vitreous hemorrhage, ultrasound at 10mhz posterior segment and 20mhz anterior segment are performed by an experienced sonographer. Patients were randomly assigned to PPV group or Ranibizumab group according to the order in which they came to visit and according to a random number table.
- PPV group: PPV and pan retinal photocoagulation; in the Ranibizumab group, Ranibizumab was injected and pan retinal photocoagulation was performed during ocular fundus could observed, and observation for 4 weeks. If vitreous hemorrhage was not absorbed/vitreous hemorrhage aggravation/proliferation membrane formation/ retinal detachment, PPV was performed.
- Collected information: best corrected visual acuity, slit lamp and fundus examination, intraocular pressure, B-ultrasound, macular thickness, the date of recurrent vitreous hemorrhage and treatment, vitreous cleaning time, the time of significant improvement of visual acuity, times and duration of vitreous hemorrhage. The follow-up time was 1 day, 2 weeks, 1 month, 2 months, 4 months and 6 months, respectively. To observe the effectiveness of Ranibizumab in the treatment of postoperative recurrent vitreous hemorrhage and reduce the number of vitrectomy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ranibizumab group | Experimental | Drug: Ranibizumab InjectionThe Ranibizumab group was treated with one intravitreal injection of 0.5 mg/0.05 ml ranibizumab (Lucentis, Basel, Novartis) at baseline. While additional panretinal photocoagulation was performed if there was sufficient space and view to fill in the previously untreated areas, if needed. Repeated injections will be given after 4 weeks when the clearing of VH was incomplete (for a maximum of two injections). If vitreous hemorrhage was not absorbed/vitreous hemorrhage aggravation/proliferation membrane formation/retinal detachment after 4 weeks of observation, the treatment was considered failed and PPV was performed. |
| PPV group | Active comparator | Procedure: PPVVitrectomy to remove vitreous hemorrhage and take additional panretinal photocoagulation. If vitreous hemorrhage was not absorbed/vitreous hemorrhage aggravation/proliferation membrane formation/tractive retinal detachment after 4 weeks of observation, the treatment was considered failed and PPV was performed. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Voluntary and able to sign an informed consent form
- Age ≥18 years
- Documented diagnosis of diabetes mellitus (type I or type II diabetes) as defined by the American Diabetes Association or World Health Organization criteria and glycosylated hemoglobin ≤10% within 2 months
- Willing and able to complete all planned visits and evaluations
- Complete Panretinal photocoagulation
Key exclusion criteria (10 listed)
- Patients with less than 6 months of follow-up
- Silicone oil filling
- Other retinal causes of vitreous hemorrhage
- Tractive retinal detachment, pre-retinal proliferative membrane
- Iris redness, neovascular glaucoma
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 InjectionAlso: Panretinal photocoagulationThe Ranibizumab group was treated with one intravitreal injection of 0.5 mg/0.05 ml ranibizumab (Lucentis, Basel, Novartis) at baseline. While additional panretinal photocoagulation was performed if there was sufficient space and view to fill in the previously untreated areas, if needed. Repeated injections will be given after 4 weeks when the clearing of VH was incomplete (for a maximum of two injections). If vitreous hemorrhage was not absorbed/vitreous hemorrhage aggravation/proliferation membrane formation/retinal detachment after 4 weeks of observation, the treatment was considered failed and PPV was performed. | Drug | Ranibizumab group |
| PPVAlso: Panretinal photocoagulationVitrectomy to remove vitreous hemorrhage and take additional panretinal photocoagulation. If vitreous hemorrhage was not absorbed/vitreous hemorrhage aggravation/proliferation membrane formation/tractive retinal detachment after 4 weeks of observation, the treatment was considered failed and PPV was performed. | Procedure or surgery | PPV group |
Primary outcome
The cleaning time of postoperative recurrent vitreous hemorrhage
Time frame: two months
Record VH by B scan and funds examination
Visual acuity
Time frame: six moths
ETDRS Alphabet Chart
3 secondary outcomes
Macular thickness
Time frame: six moths
Vitreous hemorrhage recurrence
Time frame: six moths
The number of pars plana vitrectomy
Time frame: six moths
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2022.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Ranibizumab Injection and PPV in people with Diabetic Retinopathy and Postoperative Recurrent Vitreous Hemorrhage, run by Tianjin Medical University Eye 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 8 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 12 Aug 2022. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Bojie Hu (13612130943, bhu07@tmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The cleaning time of postoperative recurrent vitreous hemorrhage (time frame: two 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?
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 12 Aug 2022.