Branch Retinal Vein OcclusionNCT03054766
Combination of Intravitreal Ranibizumab With or Without Macular Laser Photocoagulation for ME Secondary to BRVO
A study testing Ranibizumab combined macular laser and Ranibizumab in people with Branch Retinal Vein Occlusion and Ranibizumab, run by Beijing Hospital at 1 site in China.
Trial summary
To investigate the efficacy of laser photocoagulation combined with ranibizumab intravitreal injection in macular edema (ME) secondary to branch retinal vein occlusion (BRVO) in long term. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Branch Retinal Vein Occlusion, Ranibizumab, Laser Photocoagulation
- What is being tested?
- Ranibizumab combined macular laser and Ranibizumab
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 14 Feb 2017to 28 Jan 2019
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Written informed consent
- Male or female Chinese patients ≥ 18 years of age with BRVO
- Visual impairment due to ME secondary to BRVO in at least one eye with BCVA score between 73 and 24 and at least 24 letters in the other eye
Who cannot join
- Pregnant or nursing (lactating) women or women of child-bearing potential without using effective contraception
- Stroke or myocardial infarction less than 3 months prior to screening visit
- Renal failure or creatinine levels > 2.0 mg/dl
- Uncontrolled hypertension
- Active ocular infection or intraocular inflammation in any eye
- Neovascularization of the iris or neovascular glaucoma in any eye
Show all 15Show fewer
- History of uveitis or vitreomacular traction in any eye
- Treatment with any anti-angiogenic drugs within 3 months prior to baseline visit in any eye
- Glaucoma or intraocular pressure (IOP) ≥ 24 mmHg in study eye
- Active proliferative diabetic retinopathy in study eye
- Use of other investigational drugs within 30 days and systemic vascular endothecial growth factor (VEGF) antagonism drugs within 6 months prior to baseline visit
- Prior laser photocoagulation or intraocular procedure within 3 months prior to baseline in study eye
- History of intravitreal corticosteroid treatment in phakic study eye, and in aphakic or pseudophakic within 3 months prior to screening
- History of vitrectomy in study eye
- Other protocol defined inclusion /exclusion criteria may apply
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Randomized Double-blind Controlled Clinical Trial of Combination of Intravitreal Ranibizumab With or Without Macular Laser Photocoagulation for Macular Edema Secondary to Branch Retinal Vein Occlusion
To investigate the efficacy of laser photocoagulation combined with ranibizumab intravitreal injection in macular edema (ME) secondary to branch retinal vein occlusion (BRVO) in long term.
Read the detailed description
To investigate the efficacy of ranibizumab intravitreal injections-driven by achieving vision acuity stabilization compared to combination with laser photocoagulation in Chinese patients with visual impairment in ME due to BRVO.
The result of the trial will be used to support new therapy in the BRVO in China.
- Being tested
- Ranibizumab combined macular laser, Ranibizumab
- Keywords
- Laser Photocoagulation, Ranibizumab, Branch Retinal Vein Occlusion, Vascular Endothecial Growth Factor
- Medical subject headings
- Retinal Vein Occlusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ranibizumab combined macular laserProcedure or surgery
subjects in one group receive both macular laser photocoagulation and ranibizumab injections but ones in the other group just received ranibizumab injection.
RanibizumabDrug
Also called Lucentis
all subjections received 3+PRN ranibizumab injections by BCVA stabilization
| Study group | Role | What they receive |
|---|---|---|
| Ranibizumab only | Experimental | Sham macular laser photocoagulation treatment after third ranibizumab injection with PRN intravitreal injections of ranibizumab 0.5 mg guided by BCVA stabilization
Interventions :Ranibizumab injection Interventions :Sham macular laser Receives: Drug: Ranibizumab |
| Ranibizumab combined macular laser | Experimental | Macular laser photocoagulation treatment after third ranibizumab injection with PRN intravitreal injections of ranibizumab 0.5 mg guided by BCVA stabilization
Interventions :Ranibizumab injection Interventions :Macular laser photocoagulation Receives: Procedure: Ranibizumab combined macular laser; Drug: Ranibizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
visual acuity changes
comparing the changes of visual acuity between the two groups
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2017
- Study start14 Feb 2017
- Primary completion1 Feb 2018
- Study completion28 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Branch Retinal Vein OcclusionStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beijing Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Yu Xiaobing, Beijing Hospital
- Investigators
- Xiao-bing Yu, M.D, Study chair, Beijing Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03054766
- Sponsor's protocol ID
- 121-2016001
- Status last verified
- Dec 2022
- First submitted
- 5 Feb 2017
- Last updated
- 28 Dec 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: share the results of the study,and one can send message to yuxiaobing@sina.come for information
Publications
Pece A, Isola V, Piermarocchi S, Calori G. Efficacy and safety of anti-vascular endothelial growth factor (VEGF) therapy with intravitreal ranibizumab (Lucentis) for naive retinal vein occlusion: 1-year follow-up. Br J Ophthalmol. 2011 Jan;95(1):56-68. doi: 10.1136/bjo.2009.174060. Epub 2010 Jul 3.
PubMed 20601660Song S, Yu X, Zhang P, Gu X, Dai H. Combination of Ranibizumab with macular laser for macular edema secondary to branch retinal vein occlusion: one-year results from a randomized controlled double-blind trial. BMC Ophthalmol. 2020 Jun 19;20(1):241. doi: 10.1186/s12886-020-01498-7.
PubMed 32560639
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Randomized Double-blind Controlled Clinical Trial of Combination of Intravitreal Ranibizumab With or Without Macular Laser Photocoagulation for Macular Edema Secondary to Branch Retinal Vein Occlusion
- ClinicalTrials.gov ID
- NCT03054766
- Acronym / sponsor ID
- 121-2016001
- Keywords
- Laser Photocoagulation, Ranibizumab, Branch Retinal Vein Occlusion, Vascular Endothecial Growth Factor
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Beijing HospitalOther government
- Study start
- 14 Feb 2017 (actual)
- Primary completion
- 1 Feb 2018 (actual)
- Study completion
- 28 Jan 2019 (actual)
- First posted
- 16 Feb 2017 (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.
To investigate the efficacy of laser photocoagulation combined with ranibizumab intravitreal injection in macular edema (ME) secondary to branch retinal vein occlusion (BRVO) in long term.
Detailed description
To investigate the efficacy of ranibizumab intravitreal injections-driven by achieving vision acuity stabilization compared to combination with laser photocoagulation in Chinese patients with visual impairment in ME due to BRVO.
The result of the trial will be used to support new therapy in the BRVO in China.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ranibizumab only | Experimental | Drug: RanibizumabSham macular laser photocoagulation treatment after third ranibizumab injection with PRN intravitreal injections of ranibizumab 0.5 mg guided by BCVA stabilization Interventions :Ranibizumab injection Interventions :Sham macular laser |
| Ranibizumab combined macular laser | Experimental | Procedure: Ranibizumab combined macular laser, Drug: RanibizumabMacular laser photocoagulation treatment after third ranibizumab injection with PRN intravitreal injections of ranibizumab 0.5 mg guided by BCVA stabilization Interventions :Ranibizumab injection Interventions :Macular laser photocoagulation |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Written informed consent
- Male or female Chinese patients ≥ 18 years of age with BRVO
- Visual impairment due to ME secondary to BRVO in at least one eye with BCVA score between 73 and 24 and at least 24 letters in the other eye
Key exclusion criteria (15 listed)
- Pregnant or nursing (lactating) women or women of child-bearing potential without using effective contraception
- Stroke or myocardial infarction less than 3 months prior to screening visit
- Renal failure or creatinine levels > 2.0 mg/dl
- Uncontrolled hypertension
- Active ocular infection or intraocular inflammation in any eye
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 combined macular lasersubjects in one group receive both macular laser photocoagulation and ranibizumab injections but ones in the other group just received ranibizumab injection. | Procedure or surgery | Ranibizumab combined macular laser |
| RanibizumabAlso: Lucentisall subjections received 3+PRN ranibizumab injections by BCVA stabilization | Drug | Ranibizumab combined macular laser, Ranibizumab only |
Primary outcome
visual acuity changes
Time frame: one year
comparing the changes of visual acuity between the two groups
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 28 Dec 2022.
- Background: PubMed 20601660Pece A, Isola V, Piermarocchi S, Calori G. Efficacy and safety of anti-vascular endothelial growth factor (VEGF) therapy with intravitreal ranibizumab (Lucentis) for naive retinal vein occlusion: 1-year follow-up. Br J Ophthalmol. 2011 Jan;95(1):56-68. doi: 10.1136/bjo.2009.174060. Epub 2010 Jul 3.
- Derived from this study: PubMed 32560639Song S, Yu X, Zhang P, Gu X, Dai H. Combination of Ranibizumab with macular laser for macular edema secondary to branch retinal vein occlusion: one-year results from a randomized controlled double-blind trial. BMC Ophthalmol. 2020 Jun 19;20(1):241. doi: 10.1186/s12886-020-01498-7.
- Individual participant dataSharing planned: Yes. share the results of the study,and one can send message to yuxiaobing@sina.come for information
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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.
Xiao-bing Yu, M.D study chair
Beijing Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ranibizumab combined macular laser and Ranibizumab in people with Branch Retinal Vein Occlusion and Ranibizumab, run by Beijing 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 3 inclusion and 15 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 28 Dec 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.
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?
visual acuity changes (time frame: one year). 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 NCT03054766, which also lists 2 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 28 Dec 2022.