Macular EdemaNCT04601675
Diabetic Macular Edema (DME) Treatment With Ranibizumab and Dexamethasone or Ranibizumab Only.
A study testing Ranibizumab Ophthalmic and Intravitreal Dexamethasone and Ranibizumab Ophthalmic only in people with Macular Edema, run by He Eye Hospital at 1 site in China.
Trial summary
The aim of this study is to evaluate the visual outcome and prognostic factors after intraocular injections of Ranibizumab or combination of Ranibizumab And Dexamethasone under pro re nata treatment regimen for Diabetic Macular Edema patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Macular Edema
- What is being tested?
- Ranibizumab Ophthalmic and Intravitreal Dexamethasone and Ranibizumab Ophthalmic only
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 31 Oct 2020to 17 Sep 2021
- 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
- Patients with diabetic retinopathy and centre involving DMO, as determined by using spectral domain optical coherence tomography (SD-OCT), in one or both eyes with:
- Central retinal subfield thickness of > 300 but < 400 microns as determined by SD-OCT due to diabetic macular oedema OR
- Central retinal subfield thickness of < 300 microns provided that intraretinal and/or subretinal fluid is present in the central subfield (central 1 mm) related to diabetic macular oedema AND
- Visual acuity of > 24 Early Treatment Diabetic Retinopathy Study (ETDRS) letters (Snellen equivalent > 20/320)
- Amenable to laser treatment, as judged by the treating ophthalmologist
- Over 18 years of age
Who cannot join
- Eyes of patients will not be included in the study if:
- The macular oedema is due to causes other than diabetic macular oedema such as epiretinal membrane, vitreomacular traction, vein occlusion, or others
- The eye is ineligible for macular laser treatment, as judged by the treating ophthalmologist
- The eye has DMO and central subfield retinal thickness (CST) of > 400 microns.
- The eye has activeA proliferative diabetic retinopathy (PDR) requiring treatment.
- The eye has received intravitreal Anti- Vascular Endothelical Growth Factor (Anti-VEGF) therapy within the previous two months.
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- The eye has received macular laser treatment within the previous 12 months.
- The eye has received intravitreal injection of steroids.
- The eye has received cataract surgery within the previous six weeks
- The eye has received panretinal photocoagulation within the previous 3 months
- Patients on pioglitazone and the drug cannot be stopped 3 months prior to entering into the trial and for the duration of the study
- The patient has chronic renal failure requiring dialysis or kidney transplant
- The patient has any other condition that in the opinion of the investigator would preclude participation in the study (such as unstable medical status or severe disease that would make it difficult for the patient to be able to complete the study)
- The patient has very poor glycemic control and started intensive therapy within the previous 3 months
- The patient will use an investigational drug during the study
Trial locations and contacts
1 site in 1 country.
China1 site
He Eye Specialist Hospital
Shenyang, Liaoning, 110001
Jun Li, M.D., 15104083505, robin_lijun@sina.com
Emmanuel Eric E Pazo, 18612782131, ericpazo@outlook.com
About this study
Official title: Randomized Study on Diabetic Macular Edema Patients Receiving Ranibizumab and Dexamethasone or Ranibizumab Only.
The aim of this study is to evaluate the visual outcome and prognostic factors after intraocular injections of Ranibizumab or combination of Ranibizumab And Dexamethasone under pro re nata treatment regimen for Diabetic Macular Edema patients.
Read the detailed description
The aim of this study is to evaluate the clinical outcome after intraocular injections of Ranibizumab or combination of Ranibizumab and Dexamethasone under pro re nata treatment regimen for the patients with Diabetic Macular Edema patients. Mean change of logarithm of the minimal angle of resolution (logMAR) visual acuity (VA), central foveal thickness (CFT), contrast sensitivity (CS) as well as predictive factors including best-corrected visual acuity (BCVA), vision related questionnaires and various other ocular parameters will be assessed.
- Conditions
- Macular Edema
- Being tested
- Ranibizumab Ophthalmic and Intravitreal Dexamethasone, Ranibizumab Ophthalmic only
- Medical subject headings
- Macular Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ranibizumab Ophthalmic and Intravitreal DexamethasoneDrug
Also called Lucentis®, Ozurdex®
Pro re nata patients with macula edema due to diabetes will receive Ranibizumab. Group A will continue to receive Ranibizumab depending on their clinical status of macular edema
Ranibizumab Ophthalmic onlyDrug
Also called Lucentis®
Group B will initially receive intravitreal Dexamethasone and Ranibizumab and then depending on their clinical status of macular edema, Ranibizumab will be injected.
| Study group | Role | What they receive |
|---|---|---|
| Diabetic ME: Ranibizumab and intravitreal Dexamethasone | Experimental | Participants with diabetic macular edema will receive a combination of Ranibizumab and intravitreal Dexamethasone Receives: Drug: Ranibizumab Ophthalmic and Intravitreal Dexamethasone |
| Diabetic ME: Ranibizumab | Active comparator | Participants with diabetic macular edema (ME) will receive Ranibizumab only. Receives: Drug: Ranibizumab Ophthalmic only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean change in monocular BCVA in the treatment eye
Monocular BCVA in the treatment eye is assessed by using ETDRS visual acuity charts at 4 meters at baseline (pre-treatment) and 1 week, 1month, 2 months, 3 months, and 6 months after treatment.
Measured: Baseline, 1 week, 1month, 2 months, 3 months, and 6 months.
Mean change in binocular BCVA
Binocular BCVA is assessed by using ETDRS visual acuity charts at 4 meters at baseline (pre-treatment) and 1 week, 1month, 2 months, 3 months, and 6 months after treatment.
Measured: Baseline, 1 week, 1month, 2 months, 3 months, and 6 months.
Secondary outcomes (11)
Mean change in central subfield retinal thickness
Mean change in central subfield retinal thickness in the study eye, as determined by spectral domain optical coherence tomography (OCT), from baseline to 6 months.
Measured: Baseline, 1 week, 1month, 2 months, 3 months, and 6 months.
Change in Humphrey 10-2 visual field in the treatment eye
Mean deviation (MD) of the Humphrey 10-2 visual field is assessed by a Humphrey 10-2 visual field test at baseline, 1 week, 1month, 2 months, 3 months, and 6 months.
Measured: Baseline, 1 week, 1 month, 2 months, 3 months, and 6 months.
People meeting driving standards
Percentage (%) of people meeting driving standards is assessed by an Esterman binocular visual field test at baseline and and 6 months.
Measured: Baseline, 1 week, 1 month, 2 months, 3 months, and 6 months.
Mean change in NEI VFQ25
Scores from NEI VFQ25 questionnaire will be assessed and compared at baseline, 1 week, 1 month, 2 months, 3 months, and 6 months.
Measured: Baseline, 1 week, 1 month, 2 months, 3 months, and 6 months.
Mean change in EQ-5D 5L
Scores from EQ-5D 5L questionnaire will be assessed and compared at baseline, 1 week, 1 month, 2 months, 3 months, and 6 months.
Measured: Baseline, 1 week, 1 month, 2 months, 3 months, and 6 months.
Mean change in VisQoL scores
Scores from VisQoL questionnaire will be assessed and compared at baseline, 1 week, 1 month, 2 months, 3 months, and 6 months.
Measured: Baseline, 1 week, 1 month, 2 months, 3 months, and 6 months.
Mean change in wavefront aberrations
Mean deviation (MD) of wavefront aberrations is assessed by Nidek OPD Scan III test at baseline, 1 week, 1month, 2 months, 3 months, and 6 months.
Measured: Baseline, 1 week, 1 month, 2 months, 3 months, and 6 months.
Mean change in ocular surface and tear-film
Mean deviation (MD) of ocular surface and tear-film parameters is assessed by Oculus Keratographer test at baseline, 1 week, 1month, 2 months, 3 months, and 6 months.
Measured: Baseline, 1 week, 1 month, 2 months, 3 months, and 6 months.
Mean change in vessel density
Mean deviation (MD) of vessel density is assessed by Spectralis OCT2, Heidelberg-Engineering test at baseline, 1 week, 1month, 2 months, 3 months, and 6 months.
Measured: Baseline, 1 week, 1 month, 2 months, 3 months, and 6 months.
Side effects
Side effects are measured by a review of the participant's medical and ophthalmic history.
Measured: 1 week, 1 month, 2 months, 3 months, and 6 months.
Use of additional treatments (including laser)
Use of additional treatments (including laser) is assessed by the treating ophthalmologist
Measured: 1 week, 1 month, 2 months, 3 months, and 6 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2020
- Study start31 Oct 2020 (estimated)
- Primary completion1 Mar 2021 (estimated)
- Study completion17 Sep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Drug: Ozurdex intravitreal steroid Other Name: Dexamethasone Intravitreal Implant Drug: Bevacizumab antiVEGF Other Name: Avastin
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- He Eye Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wei He, M.D., Ph.D., Study chair, He Eye Specialist Hospital, Shenyang.Jun Li, M.D., Ph.D., Principal investigator, He Eye Specialist Hospital, Shenyang.Emmanuel E Pazo, M.D., Ph.D., Study director, He Eye Specialist Hospital, Shenyang.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04601675
- Sponsor's protocol ID
- ME-230620
- Status last verified
- Jun 2020
- First submitted
- 20 Oct 2020
- Last updated
- 26 Oct 2020
- Results posted
- No
- Data monitoring committee
- Yes
- 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 26 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Study on Diabetic Macular Edema Patients Receiving Ranibizumab and Dexamethasone or Ranibizumab Only.
- ClinicalTrials.gov ID
- NCT04601675
- Acronym / sponsor ID
- ME-230620
- Conditions
- Macular Edema
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- He Eye HospitalUniversity, hospital or other
- Study start
- 31 Oct 2020 (estimated)
- Primary completion
- 1 Mar 2021 (estimated)
- Study completion
- 17 Sep 2021 (estimated)
- First posted
- 26 Oct 2020 (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 aim of this study is to evaluate the visual outcome and prognostic factors after intraocular injections of Ranibizumab or combination of Ranibizumab And Dexamethasone under pro re nata treatment regimen for Diabetic Macular Edema patients.
Detailed description
The aim of this study is to evaluate the clinical outcome after intraocular injections of Ranibizumab or combination of Ranibizumab and Dexamethasone under pro re nata treatment regimen for the patients with Diabetic Macular Edema patients. Mean change of logarithm of the minimal angle of resolution (logMAR) visual acuity (VA), central foveal thickness (CFT), contrast sensitivity (CS) as well as predictive factors including best-corrected visual acuity (BCVA), vision related questionnaires and various other ocular parameters will be assessed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Drug: Ozurdex intravitreal steroid Other Name: Dexamethasone Intravitreal Implant Drug: Bevacizumab antiVEGF Other Name: Avastin
| Arm | Type | Receives |
|---|---|---|
| Diabetic ME: Ranibizumab and intravitreal Dexamethasone | Experimental | Drug: Ranibizumab Ophthalmic and Intravitreal DexamethasoneParticipants with diabetic macular edema will receive a combination of Ranibizumab and intravitreal Dexamethasone |
| Diabetic ME: Ranibizumab | Active comparator | Drug: Ranibizumab Ophthalmic onlyParticipants with diabetic macular edema (ME) will receive Ranibizumab only. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients with diabetic retinopathy and centre involving DMO, as determined by using spectral domain optical coherence tomography (SD-OCT), in one or both eyes with:
- Central retinal subfield thickness of > 300 but < 400 microns as determined by SD-OCT due to diabetic macular oedema OR
- Central retinal subfield thickness of < 300 microns provided that intraretinal and/or subretinal fluid is present in the central subfield (central 1 mm) related to diabetic macular oedema AND
- Visual acuity of > 24 Early Treatment Diabetic Retinopathy Study (ETDRS) letters (Snellen equivalent > 20/320)
- Amenable to laser treatment, as judged by the treating ophthalmologist
Key exclusion criteria (15 listed)
- The macular oedema is due to causes other than diabetic macular oedema such as epiretinal membrane, vitreomacular traction, vein occlusion, or others
- The eye is ineligible for macular laser treatment, as judged by the treating ophthalmologist
- The eye has DMO and central subfield retinal thickness (CST) of > 400 microns.
- The eye has activeA proliferative diabetic retinopathy (PDR) requiring treatment.
- The eye has received intravitreal Anti- Vascular Endothelical Growth Factor (Anti-VEGF) therapy within the previous two months.
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 Ophthalmic and Intravitreal DexamethasoneAlso: Lucentis®, Ozurdex®Pro re nata patients with macula edema due to diabetes will receive Ranibizumab. Group A will continue to receive Ranibizumab depending on their clinical status of macular edema | Drug | Diabetic ME: Ranibizumab and intravitreal Dexamethasone |
| Ranibizumab Ophthalmic onlyAlso: Lucentis®Group B will initially receive intravitreal Dexamethasone and Ranibizumab and then depending on their clinical status of macular edema, Ranibizumab will be injected. | Drug | Diabetic ME: Ranibizumab |
Primary outcome
Mean change in monocular BCVA in the treatment eye
Time frame: Baseline, 1 week, 1month, 2 months, 3 months, and 6 months.
Monocular BCVA in the treatment eye is assessed by using ETDRS visual acuity charts at 4 meters at baseline (pre-treatment) and 1 week, 1month, 2 months, 3 months, and 6 months after treatment.
Mean change in binocular BCVA
Time frame: Baseline, 1 week, 1month, 2 months, 3 months, and 6 months.
Binocular BCVA is assessed by using ETDRS visual acuity charts at 4 meters at baseline (pre-treatment) and 1 week, 1month, 2 months, 3 months, and 6 months after treatment.
11 secondary outcomes
Mean change in central subfield retinal thickness
Time frame: Baseline, 1 week, 1month, 2 months, 3 months, and 6 months.
Change in Humphrey 10-2 visual field in the treatment eye
Time frame: Baseline, 1 week, 1 month, 2 months, 3 months, and 6 months.
People meeting driving standards
Time frame: Baseline, 1 week, 1 month, 2 months, 3 months, and 6 months.
Mean change in NEI VFQ25
Time frame: Baseline, 1 week, 1 month, 2 months, 3 months, and 6 months.
Mean change in EQ-5D 5L
Time frame: Baseline, 1 week, 1 month, 2 months, 3 months, and 6 months.
Mean change in VisQoL scores
Time frame: Baseline, 1 week, 1 month, 2 months, 3 months, and 6 months.
Mean change in wavefront aberrations
Time frame: Baseline, 1 week, 1 month, 2 months, 3 months, and 6 months.
Mean change in ocular surface and tear-film
Time frame: Baseline, 1 week, 1 month, 2 months, 3 months, and 6 months.
Mean change in vessel density
Time frame: Baseline, 1 week, 1 month, 2 months, 3 months, and 6 months.
Side effects
Time frame: 1 week, 1 month, 2 months, 3 months, and 6 months.
Use of additional treatments (including laser)
Time frame: 1 week, 1 month, 2 months, 3 months, and 6 months.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2020.
- 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.
Wei He, M.D., Ph.D. study chair
He Eye Specialist Hospital, Shenyang.
Jun Li, M.D., Ph.D. principal investigator
He Eye Specialist Hospital, Shenyang.
Emmanuel E Pazo, M.D., Ph.D. study director
He Eye Specialist Hospital, Shenyang.
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 Ophthalmic and Intravitreal Dexamethasone and Ranibizumab Ophthalmic only in people with Macular Edema, run by He 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 6 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: status not confirmed, as of the sponsor's last update on 26 Oct 2020. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jun Li, M.D., Ph.D. (0411-86525401, robin_lijun@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean change in monocular BCVA in the treatment eye (time frame: Baseline, 1 week, 1month, 2 months, 3 months, and 6 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 26 Oct 2020.