Diabetic Macular EdemaPhase 4NCT03690947
Combination of Intravitreal Ranibizumab With or Without Micropulse Laser for the Treatment of DME
A Phase 4 study testing Intravitreal Ranibizumab, Micropulse Laser and Intravitreal Ranibizumab as needed in people with Diabetic Macular Edema, run by Beijing Hospital at 1 site in China.
Trial summary
The objective of this study is to evaluate if combination of intravitreal ranibizumab with micropulse laser shows non inferiority compared to intravitreal ranibizumab only in diabetic macular edema. Read more about this study
- Who is it for?
- Ages 30 to 80 years
- Conditions the study is for
- Diabetic Macular Edema
- What is being tested?
- Intravitreal Ranibizumab, Micropulse Laser and Intravitreal Ranibizumab as needed
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2018to 30 Sep 2021
- 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 30 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Informed consent form must be signed before any tests or procedures are done
- Male or female of 30 to 80 years of age (inclusive) at the first screening visit
- Diagnosis of type 2 diabetes, with fasting blood glucose≤10mmol/L, HbA1C≤10.0%
- Diabetic medication must be stable for at least 3 months before first screening visit and remain stable during study
- Diagnosis of non-proliferative diabetic retinopathy with diabetic macular edema resulting in visual acuity reduction
- Study eye's BCVA between 24 to 78 ETDRS letters at screening and baseline of the study
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- Macular edema of the study eye and central retinal thickness ≥300 µm determined by SD-OCT
- Study eye had not had grid pattern photocoagulation, intraocular surgery, intravitreal corticosteroid injections and intravitreal anti-VEGF injections for at least 3 months before baseline
- Non-study eye's BCVA ≥ 24 ETDRS letters at screening and baseline of the study
- Non-study eye had not had intravitreal anti-VEGF injections for at least 3 months before baseline
- If both eyes qualify, then investigators will choose an eye with worse BCVA as study eye. Only study eye will receive intravitreal ranibizumab and/or Micropulse Laser treatment
Who cannot join
- Failure to follow study or follow-up procedures
- Pregnant or breast-feeding woman and woman without adequate method of contraception
- History of stroke or myocardial infarction within 3 months before screening
- Renal failure or creatinine > 2.0 mg/dl
- Uncontrolled systemic diseases or systemic treatment that may affect results of the study
- Active ocular or intraocular infections of either eye
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- Neovascularization of the iris or neovascular glaucoma of either eye
- A history of uveitis or vitreous macular traction in study eye
- Glaucoma or IOP≥24 mmHg of study eye
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized, Double-blinded, Controlled Clinical Trial of Combination of Intravitreal Ranibizumab With or Without Micropulse Laser for the Treatment of Diabetic Macular Edema
The objective of this study is to evaluate if combination of intravitreal ranibizumab with micropulse laser shows non inferiority compared to intravitreal ranibizumab only in diabetic macular edema.
Read the detailed description
To investigate the efficacy of intravitreal ranibizumab injections compared to combination with Micropulse Laser in Chinese patients with visual impairment in DME.
The result of the study will be used to support new therapy in DME patients in China.
- Conditions
- Diabetic Macular Edema
- Being tested
- Intravitreal Ranibizumab, Micropulse Laser, Intravitreal Ranibizumab as needed
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intravitreal RanibizumabDrug
Also called Lucentis
All subjections received 3 initial Ranibizumab injections
Micropulse LaserProcedure or surgery
Also called Macular Laser Photocoagulation
After 3 initial Ranibizumab injections, Micropulse Laser will be done as needed each month if macular edema persists
Intravitreal Ranibizumab as neededDrug
Also called Lucentis
After 3 initial Ranibizumab injections, Ranibizumab will be injected as needed till BCVA reaches stabilization
| Study group | Role | What they receive |
|---|---|---|
| Combination Therapy Group | Experimental | Not described Receives: Drug: Intravitreal Ranibizumab; Procedure: Micropulse Laser |
| Intravitreal Ranibizumab Group | Active comparator | Not described Receives: Drug: Intravitreal Ranibizumab; Drug: Intravitreal Ranibizumab as needed |
What is being measured
The primary outcome is the main question the study is designed to answer.
Best Corrected Visual Acuity changes
Compare the changes of BCVA between two groups
Measured: 12 months
Secondary outcomes (1)
Central Macular Thickness changes
Compare the changes of CMT between two groups
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 posted1 Oct 2018
- Study start1 Oct 2018
- Primary completion31 Aug 2021
- Study completion30 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetic Macular EdemaStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beijing Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Yu Xiaobing, Beijing Hospital
- Investigators
- Xiaobing Yu, M.D., Principal investigator, Beijing Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03690947
- Sponsor's protocol ID
- Z181100001718079
- Status last verified
- Dec 2022
- First submitted
- 28 Sep 2018
- Last updated
- 28 Dec 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Email yuxiaobing@sina.com for individual participant data
Publications
Mi X, Gu X, Yu X. The efficacy of micropulse laser combined with ranibizumab in diabetic macular edema treatment: study protocol for a randomized controlled trial. Trials. 2022 Sep 2;23(1):736. doi: 10.1186/s13063-022-06593-2.
PubMed 36056443
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
- Randomized, Double-blinded, Controlled Clinical Trial of Combination of Intravitreal Ranibizumab With or Without Micropulse Laser for the Treatment of Diabetic Macular Edema
- ClinicalTrials.gov ID
- NCT03690947
- Acronym / sponsor ID
- Z181100001718079
- Conditions
- Diabetic Macular Edema
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Beijing HospitalOther government
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 31 Aug 2021 (actual)
- Study completion
- 30 Sep 2021 (actual)
- First posted
- 1 Oct 2018 (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.
The objective of this study is to evaluate if combination of intravitreal ranibizumab with micropulse laser shows non inferiority compared to intravitreal ranibizumab only in diabetic macular edema.
Detailed description
To investigate the efficacy of intravitreal ranibizumab injections compared to combination with Micropulse Laser in Chinese patients with visual impairment in DME.
The result of the study will be used to support new therapy in DME patients in China.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Combination Therapy Group | Experimental | Drug: Intravitreal Ranibizumab, Procedure: Micropulse Laser |
| Intravitreal Ranibizumab Group | Active comparator | Drug: Intravitreal Ranibizumab, Drug: Intravitreal Ranibizumab as needed |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Informed consent form must be signed before any tests or procedures are done
- Male or female of 30 to 80 years of age (inclusive) at the first screening visit
- Diagnosis of type 2 diabetes, with fasting blood glucose≤10mmol/L, HbA1C≤10.0%
- Diabetic medication must be stable for at least 3 months before first screening visit and remain stable during study
- Diagnosis of non-proliferative diabetic retinopathy with diabetic macular edema resulting in visual acuity reduction
Key exclusion criteria (9 listed)
- Failure to follow study or follow-up procedures
- Pregnant or breast-feeding woman and woman without adequate method of contraception
- History of stroke or myocardial infarction within 3 months before screening
- Renal failure or creatinine > 2.0 mg/dl
- Uncontrolled systemic diseases or systemic treatment that may affect results of the study
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 |
|---|---|---|
| Intravitreal RanibizumabAlso: LucentisAll subjections received 3 initial Ranibizumab injections | Drug | Combination Therapy Group, Intravitreal Ranibizumab Group |
| Micropulse LaserAlso: Macular Laser PhotocoagulationAfter 3 initial Ranibizumab injections, Micropulse Laser will be done as needed each month if macular edema persists | Procedure or surgery | Combination Therapy Group |
| Intravitreal Ranibizumab as neededAlso: LucentisAfter 3 initial Ranibizumab injections, Ranibizumab will be injected as needed till BCVA reaches stabilization | Drug | Intravitreal Ranibizumab Group |
Primary outcome
Best Corrected Visual Acuity changes
Time frame: 12 months
Compare the changes of BCVA between two groups
1 secondary outcome
Central Macular Thickness changes
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 28 Dec 2022.
- Derived from this study: PubMed 36056443Mi X, Gu X, Yu X. The efficacy of micropulse laser combined with ranibizumab in diabetic macular edema treatment: study protocol for a randomized controlled trial. Trials. 2022 Sep 2;23(1):736. doi: 10.1186/s13063-022-06593-2.
- Individual participant dataSharing planned: Yes. Email yuxiaobing@sina.com for individual participant data
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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.
Xiaobing Yu, M.D. principal investigator
Beijing Hospital
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 Intravitreal Ranibizumab, Micropulse Laser and Intravitreal Ranibizumab as needed in people with Diabetic Macular Edema, 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 11 inclusion and 9 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.
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?
Best Corrected Visual Acuity changes (time frame: 12 months). 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 NCT03690947, which also lists 1 linked publication.
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.