Mild Non-proliferative Diabetic RetinopathyPhase 4NCT05386160
Phacoemulsification Combined With Intravitreal Injection of Ranibizumab Prevent Postoperative Capillary Non-perfusion Zone Progress in Non-proliferative Diabetic Retinopathy
A Phase 4 study testing Ranibizumab Injection [Lucentis] and Phacoemulsification in people with Mild Non-proliferative Diabetic Retinopathy and Cataract Diabetic, run by Ruijin Hospital at 1 site in China.
Trial summary
Diabetic retinopathy has been found progress in 20-70% diabetic patient after cataract phacoemulsification surgery. Intravitreal injection of anti-VEGF Ranibizumab is an important treatment for diabetic retinopathy including non-proliferative diabetic retinopathy (NPDR). Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Mild Non-proliferative Diabetic Retinopathy, Cataract Diabetic, Diabetic Retinopathy
- What is being tested?
- Ranibizumab Injection [Lucentis] and Phacoemulsification
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2022to 1 Mar 2023
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed and dated informed consent
- Commitment to follow the research procedures and cooperate with the implementation of the whole process of research
- No specific gender, 18+ years old
- Diagnosed in line with NPDR,
- Phacoemulsification combined with anti-VEGF therapy is planned
- No obvious surgical contraindications
Who cannot join
- Use of other investigational drug treatments or take part in other types of clinical studies
- Allergy to anti-VEGF drugs
- Patients with other macular and optic disc diseases
- Patients with meaningful diabetic macular edema
- Patient with surgical complications
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of Ophthalmology, Ruijin Hospital Affiliated Medical,Shanghai Jiaotong University School
Shanghai, Shanghai Municipality, 200025
Zijian Yang, Dr., 18121261251, dyangzj@163.com
Huiping Yao, Dr.
About this study
Official title: Department of Ophthalmology, Ruijin Hospital, Affiliated Medical School, Shanghai Jiaotong University
Diabetic retinopathy has been found progress in 20-70% diabetic patient after cataract phacoemulsification surgery. Intravitreal injection of anti-VEGF Ranibizumab is an important treatment for diabetic retinopathy including non-proliferative diabetic retinopathy (NPDR). However, there is no research about phacoemulsification surgery combine Intravitreal injection of Ranibizumab on diabetic retinopathy. The research focus on the effect of phacoemulsification surgery combine intravitreal injection of Ranibizumab on mild non-proliferative diabetic retinopathy and explore the reasons for differences in treatment outcomes.
Read the detailed description
This research is a single-center prospective, randomized controlled study. Patient were divided into two groups, the control group is phacoemulsification surgery group and the intervention group is phacoemulsification surgery combine intravitreal injection of Ranibizumab group. Eye examination including visual acuity, intraocular pressure(IOP), fundus fluoroscopy, macular optical coherence tomograph（OCT） examination, were taken before cataract surgery. The anterior aqueous humor was extracted before cataract phacoemulsification in the combined operation group, and 0.05 ml of ranibizumab was injected into the vitreous immediately after the operation. The aqueous humor concentrations of vascular endothelial growth factor（VEGF）, interleukin（IL）IL-2, IL-4, and Tumor Necrosis Factor（TNF） were checked by real-time polymerase chain reaction assay（RT-PCR） and ELISA analysis. The Best Corrected Visual Acuity（BCVA）, IOP and fundus lesions changes were observed in the two groups after operation. Diabetic retinopathy capillary non-perfusion zone were evaluated one year after phacoemulsification surgery.
- Being tested
- Ranibizumab Injection [Lucentis], Phacoemulsification
- Keywords
- Phaco, VEGF, diabetic retinopathy
- 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 Injection [Lucentis]Drug
Also called Phacoemulsification
intravitreal injection of Ranibizumab；
PhacoemulsificationDevice
Phacoemulsification
| Study group | Role | What they receive |
|---|---|---|
| Cataract phacoemulsification combines Ranibizumab | Active comparator | 0.05 ml of ranibizumab was injected into the vitreous immediately after the operation Receives: Drug: Ranibizumab Injection [Lucentis] |
| Cataract phacoemulsification | Active comparator | 0.05 ml of ranibizumab was injected into the vitreous immediately after the operation Receives: Drug: Ranibizumab Injection [Lucentis]; Device: Phacoemulsification |
What is being measured
The primary outcome is the main question the study is designed to answer.
capillary non-perfusion zone of non-proliferative diabetic retinopathy
Patient were divided into two groups, the control group is phacoemulsification surgery group and the intervention group is phacoemulsification surgery combine intravitreal injection of Ranibizumab group. Eye examination including visual acuity, intraocular pressure (IOP), fundus fluoroscopy, macular OCT examination, were taken before cataract surgery. The anterior aqueous humor was extracted before cataract phacoemulsification in the combined operation group, and 0.05 ml of ranibizumab was injected into the vitreous immediately after the operation. The BCVA, IOP and fundus lesions changes were observed in the two groups after operation. Diabetic retinopathy capillary non-perfusion zone were evaluated one year after phacoemulsification surgery.
Measured: 1 year
Secondary outcomes (1)
Determination of inflammatory factors in anterior aqueous humor
The anterior aqueous humor was extracted before cataract phacoemulsification in the combined operation group. The aqueous humor concentrations of VEGF, IL-2, IL-4, and TNF were checked by RT-PCR and ELISA analysis.
Measured: before cataract phacoemulsification
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2022
- Study start1 Jul 2022 (estimated)
- Primary completion1 Mar 2023 (estimated)
- Study completion1 Mar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild Non-proliferative 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- This research is a single-center prospective, randomized controlled study. Patient were divided into two groups, the control group is phacoemulsification surgery group and the intervention group is phacoemulsification surgery combine intravitreal injection of Ranibizumab group.
- Masking
- None (open label)
- Enrolment
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Zijian Yang, Dr, Study director, Department of Ophthalmology, Ruijin Hospital north, Affiliated Medical School, Shanghai Jiaotong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05386160
- Sponsor's protocol ID
- RuijinH202201
- Status last verified
- Jan 2022
- First submitted
- 26 Apr 2022
- Last updated
- 23 May 2022
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Department of Ophthalmology, Ruijin Hospital, Affiliated Medical School, Shanghai Jiaotong University
- ClinicalTrials.gov ID
- NCT05386160
- Acronym / sponsor ID
- RuijinH202201
- Keywords
- Phaco, VEGF, diabetic retinopathy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Study start
- 1 Jul 2022 (estimated)
- Primary completion
- 1 Mar 2023 (estimated)
- Study completion
- 1 Mar 2023 (estimated)
- First posted
- 23 May 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 has been found progress in 20-70% diabetic patient after cataract phacoemulsification surgery. Intravitreal injection of anti-VEGF Ranibizumab is an important treatment for diabetic retinopathy including non-proliferative diabetic retinopathy (NPDR). However, there is no research about phacoemulsification surgery combine Intravitreal injection of Ranibizumab on diabetic retinopathy. The research focus on the effect of phacoemulsification surgery combine intravitreal injection of Ranibizumab on mild non-proliferative diabetic retinopathy and explore the reasons for differences in treatment outcomes.
Detailed description
This research is a single-center prospective, randomized controlled study. Patient were divided into two groups, the control group is phacoemulsification surgery group and the intervention group is phacoemulsification surgery combine intravitreal injection of Ranibizumab group. Eye examination including visual acuity, intraocular pressure(IOP), fundus fluoroscopy, macular optical coherence tomograph（OCT） examination, were taken before cataract surgery. The anterior aqueous humor was extracted before cataract phacoemulsification in the combined operation group, and 0.05 ml of ranibizumab was injected into the vitreous immediately after the operation. The aqueous humor concentrations of vascular endothelial growth factor（VEGF）, interleukin（IL）IL-2, IL-4, and Tumor Necrosis Factor（TNF） were checked by real-time polymerase chain reaction assay（RT-PCR） and ELISA analysis. The Best Corrected Visual Acuity（BCVA）, IOP and fundus lesions changes were observed in the two groups after operation. Diabetic retinopathy capillary non-perfusion zone were evaluated one year after phacoemulsification surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This research is a single-center prospective, randomized controlled study. Patient were divided into two groups, the control group is phacoemulsification surgery group and the intervention group is phacoemulsification surgery combine intravitreal injection of Ranibizumab group.
| Arm | Type | Receives |
|---|---|---|
| Cataract phacoemulsification combines Ranibizumab | Active comparator | Drug: Ranibizumab Injection [Lucentis]0.05 ml of ranibizumab was injected into the vitreous immediately after the operation |
| Cataract phacoemulsification | Active comparator | Drug: Ranibizumab Injection [Lucentis], Device: Phacoemulsification0.05 ml of ranibizumab was injected into the vitreous immediately after the operation |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Signed and dated informed consent
- Commitment to follow the research procedures and cooperate with the implementation of the whole process of research
- No specific gender, 18+ years old
- Diagnosed in line with NPDR,
- Phacoemulsification combined with anti-VEGF therapy is planned
Key exclusion criteria (5 listed)
- Use of other investigational drug treatments or take part in other types of clinical studies
- Allergy to anti-VEGF drugs
- Patients with other macular and optic disc diseases
- Patients with meaningful diabetic macular edema
- Patient with surgical complications
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 Injection [Lucentis]Also: Phacoemulsificationintravitreal injection of Ranibizumab； | Drug | Cataract phacoemulsification, Cataract phacoemulsification combines Ranibizumab |
| PhacoemulsificationPhacoemulsification | Device | Cataract phacoemulsification |
Primary outcome
capillary non-perfusion zone of non-proliferative diabetic retinopathy
Time frame: 1 year
Patient were divided into two groups, the control group is phacoemulsification surgery group and the intervention group is phacoemulsification surgery combine intravitreal injection of Ranibizumab group. Eye examination including visual acuity, intraocular pressure (IOP), fundus fluoroscopy, macular OCT examination, were taken before cataract surgery. The anterior aqueous humor was extracted before cataract phacoemulsification in the combined operation group, and 0.05 ml of ranibizumab was injected into the vitreous immediately after the operation. The BCVA, IOP and fundus lesions changes were observed in the two groups after operation. Diabetic retinopathy capillary non-perfusion zone were evaluated one year after phacoemulsification surgery.
1 secondary outcome
Determination of inflammatory factors in anterior aqueous humor
Time frame: before cataract phacoemulsification
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 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.
Zijian Yang, Dr study director
Department of Ophthalmology, Ruijin Hospital north, Affiliated Medical School, Shanghai Jiaotong 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 Ranibizumab Injection [Lucentis] and Phacoemulsification in people with Mild Non-proliferative Diabetic Retinopathy and Cataract Diabetic, 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 6 inclusion and 5 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 23 May 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zijian Yang, Dr. (+862167888999 ext. 88024, dyangzj@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
capillary non-perfusion zone of non-proliferative diabetic retinopathy (time frame: 1 year). 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 23 May 2022.