Visual Acuity Reduced TransientlyPhase 4DORONCT02665689
Influence of Diabetes Control on Treatment of Diabetic Macular Edema With Ranibizumab
A Phase 4 study testing ranibizumab in people with Visual Acuity Reduced Transiently and Macular Edema, Cystoid, run by Prof. Dr. Antonia M. Joussen at 1 site in Germany.
Trial summary
The aim of the prospective randomized study is to investigate whether a intensified diabetic control program leads to better final visual acuity and less frequent diabetic ocular complications in patients with diabetic retinopathy when compared with a normal diabetic treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Visual Acuity Reduced Transiently, Macular Edema, Cystoid
- What is being tested?
- ranibizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteGermany
- Study dates
- 18 Jan 2016to 7 Sep 2018
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 macular edema relevant to visual acuity
- OCT central retinal thickness ≥ 250µm
- HbA1c > 6,5% at initial visit
- BCVA ≤0.8 and ≥0.05
- Age ≥18 years
- Written patient informed consent given
Who cannot join
- Previous treatment with intravitreal drugs in last 6 months
- Vitreous hemorrhage as a consequence of proliferative retinopathy
- Pregnancy
- Blood pressure of ≥ 180/100 (or uncontrolled pressures under pharmacological therapy)
- Chronic systemic or ocular inflammatory/autoimmune diseases (e.g. inflammatory bowel disease, Addison´s disease, Cushing Syndrome, Uveitis)
- Systemic cortisone or anti-VEGF therapy
- Acute systemic or ocular infectious diseases
Trial locations and contacts
1 site in 1 country.
About this study
The aim of the prospective randomized study is to investigate whether a intensified diabetic control program leads to better final visual acuity and less frequent diabetic ocular complications in patients with diabetic retinopathy when compared with a normal diabetic treatment.
Read the detailed description
Patients with diabetic macular edema (DME) will be treated with intravitreal ranibizumab injections and the effect of optimal control of internal factors (eg. glycemia, blood pressure etc) on final functional (best corrected visual acuity-CBVA) and morphological (central retinal thickness-CRT) will be investigated. Patients will be randomized into two groups: Group with intensified diabetic control will be follow and investigated monthly at department of diabetology, endocrinology and nutritional medicine (Campus Benjamin Franklin) in Berlin with aim to reach the optimal glycemic control defined as HbA1c < 6,5%. Further, triglycerides values < 140 mg/dl and blood pressure < 140/90 mmHg will be pursued. Second group of patients will be followed by their general practitioner and in the study center only blood samples will be taken quarterly without active medical intervention.
BCVA, CRT and the number of required ranibizumab injections will we evaluated and compared between both study groups.
- Being tested
- ranibizumab
- Keywords
- Diabetic Macular Edema, Ranibizumab, Visual Acuity, Diabetic Control
- Medical subject headings
- Macular Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ranibizumabDrug
Ranibizumab injections will be given for diabetic macular edema. In the experimental arm insulin injections and antihypertensiva will be applied.
| Study group | Role | What they receive |
|---|---|---|
| Regular Glycemic Control | Active comparator | Diabetic macular edema will be treated with 3 monthly ranibizumab (0,5mg) injections followed by PRN regimen. Patients randomized into this group will be controlled by their general practitioner or private diabetologist (usual care). The glycemic control (blood measurements of HbA1c) will be performed at trial site (Department of diabetology, endocrinology and nutritional medicine) every 3 months. The site will not influence or change the diabetes medication given by general physician and serves as an observer only to monitor the diabetic control. Receives: Drug: ranibizumab |
| Intensified Glycemic Control | Experimental | Diabetic macular edema will be treated with 3 monthly ranibizumab (0,5mg) injections followed by PRN regimen.
Patients randomized into this group will be controlled at the trial site (Department of diabetology, endocrinology and nutritional medicine) during first year monthly, in the second study year every 3 months. The individual HbA1c will be targeted according to the general status reflecting other risk factors for the vasculopathy (e.g. BMI, smoking, blood pressure, lipid status). All effort will be done to reach the target blood pressure ≤ 140/90 mmHg and blood triglyceride level < 140 mg/dl: Further the patients will be educated to improve their eating habits in regard to reduce the carbohydrate intake. Receives: Drug: ranibizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference of Best Corrected Visual Acuity Measured in ETDRS Letters Score Between Month 12 Baseline Visit
Measured by the difference in ETDRS letters score between month 12 and baseline according to internal guideline of Charité department of ophthalmology.
Measured: Baseline to 12 months
Secondary outcomes (7)
Number of Treatments With Ranibizumab up to 6, 12, 18 and 24 Months of Treatment
For the number of treatments at 6, 12, 18 and 24 months, an ANOVA without any covariates was planned to be applied at each endpoint 6, 12, 18 and 24 months.
As the time point 12 months for the evaluation of this secondary endpoint was reached only for patients of study arm B, a comparison of both study arms was not possible and thus statistical analysis of the endpoint was waived completely. None of the patients reached time points beyond month 12.
Results are only shown descriptively. Ranibizumab injections were summed up per study arm as well as cumulative at each time point.
Measured: Baseline to 12 months
Difference of Best Corrected Visual Acuity Measured in ETDRS Letters Score Between Month 6, 12, 24 and Baseline Visit
As the time point 12 months for the evaluation of this secondary endpoint was reached only for patients of study arm B, a comparison of both study arms was not possible and thus analysis of the endpoint was waived completely. Time point 24 months was reached by none of the patients due to trial discontinuation. Results are only shown descriptively.
Best-corrected visual acuity (BCVA) score is shown as change in ETDRS letters score at the distinct time point compared to baseline. Higher scores mean a better outcome.
Measured: Baseline to 12 months
Macular Thickness Change at 6, 12, 18 and 24 Months Compared to Baseline
As the time point 12 months for the evaluation of this secondary endpoint was reached only for patients of study arm B, a comparison of both study arms was not possible and thus analysis of the endpoint was waived completely. None of the patients reached time points beyond month 12 due to trial discontinuation. Results are only shown descriptively.
Macular thickness (study eye) is shown as change in thickness [µm] compared to individual baseline value. A reduction in thickness means improvement.
Measured: Baseline to 12 months
Time to Reach Target HbA1c
Measured: 24 months
Number of Panretinal Laser Photocoagulation (PRP) Treatments Necessary for Neovascular Complications
Need for PRP is up to the investigator's decision. Assessment was done on every visit.
Intended time frame was baseline to 24 months. None of the patients reached time points beyond month 12 due to study discontinuation.
Unit of measure is any separate investigator's decision to perform panretinal laser photocoagulation (PRP) for neovascular complications. Each PRP is counted separately.
Measured: Baseline to 12 months
Number of Participants With Retinal Detachment, Central Retinal Artery Occlusion, or Endophthalmitis and/or Ocular Adverse Events That Are Related to Treatment
All ocular adverse events presented from baseline to 24 months will be documented.
Measured: Baseline to 12 months
Number of Participants With Abnormal Laboratory Values and/or Adverse Events That Are Related to Treatment
All adverse events were documented. Causal relationship to study treatment was assessed by the investigators.
Intended time frame was baseline to 24 months. None of the patients reached time points beyond 12 months due to study discontinuation.
Measured: Baseline to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2016 (estimated)
- Study start18 Jan 2016
- Primary completion7 Sep 2018
- Study completion7 Sep 2018
Why it stopped: Enrollment pace was far below target.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Visual Acuity Reduced TransientlyStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prof. Dr. Antonia M. Joussen
- Sponsor type
- University, hospital or other
- Collaborators
- Charite University, Berlin, Germany
- Responsible party
- Sponsor-investigator, Prof. Dr. Antonia M. Joussen, Charite University, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02665689
- Sponsor's protocol ID
- DORO001
- Acronym
- DORO
- Status last verified
- Oct 2019
- First submitted
- 21 Jan 2016
- Last updated
- 20 Nov 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Diabetes Control on Treatment of Diabetic Macular Edema With Ranibizumab
- ClinicalTrials.gov ID
- NCT02665689
- Acronym / sponsor ID
- DORO / DORO001
- Keywords
- Diabetic Macular Edema, Ranibizumab, Visual Acuity, Diabetic Control
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Enrollment pace was far below target.
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Prof. Dr. Antonia M. JoussenUniversity, hospital or other
- Collaborators
- Charite University, Berlin, Germany
- Study start
- 18 Jan 2016 (actual)
- Primary completion
- 7 Sep 2018 (actual)
- Study completion
- 7 Sep 2018 (actual)
- First posted
- 28 Jan 2016 (estimated)
- Results
- Posted 20 Nov 2019
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 the prospective randomized study is to investigate whether a intensified diabetic control program leads to better final visual acuity and less frequent diabetic ocular complications in patients with diabetic retinopathy when compared with a normal diabetic treatment.
Detailed description
Patients with diabetic macular edema (DME) will be treated with intravitreal ranibizumab injections and the effect of optimal control of internal factors (eg. glycemia, blood pressure etc) on final functional (best corrected visual acuity-CBVA) and morphological (central retinal thickness-CRT) will be investigated. Patients will be randomized into two groups: Group with intensified diabetic control will be follow and investigated monthly at department of diabetology, endocrinology and nutritional medicine (Campus Benjamin Franklin) in Berlin with aim to reach the optimal glycemic control defined as HbA1c < 6,5%. Further, triglycerides values < 140 mg/dl and blood pressure < 140/90 mmHg will be pursued. Second group of patients will be followed by their general practitioner and in the study center only blood samples will be taken quarterly without active medical intervention.
BCVA, CRT and the number of required ranibizumab injections will we evaluated and compared between both study groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Regular Glycemic Control | Active comparator | Drug: ranibizumabDiabetic macular edema will be treated with 3 monthly ranibizumab (0,5mg) injections followed by PRN regimen. Patients randomized into this group will be controlled by their general practitioner or private diabetologist (usual care). The glycemic control (blood measurements of HbA1c) will be performed at trial site (Department of diabetology, endocrinology and nutritional medicine) every 3 months. The site will not influence or change the diabetes medication given by general physician and serves as an observer only to monitor the diabetic control. |
| Intensified Glycemic Control | Experimental | Drug: ranibizumabDiabetic macular edema will be treated with 3 monthly ranibizumab (0,5mg) injections followed by PRN regimen. Patients randomized into this group will be controlled at the trial site (Department of diabetology, endocrinology and nutritional medicine) during first year monthly, in the second study year every 3 months. The individual HbA1c will be targeted according to the general status reflecting other risk factors for the vasculopathy (e.g. BMI, smoking, blood pressure, lipid status). All effort will be done to reach the target blood pressure ≤ 140/90 mmHg and blood triglyceride level < 140 mg/dl: Further the patients will be educated to improve their eating habits in regard to reduce the carbohydrate intake. |
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 macular edema relevant to visual acuity
- OCT central retinal thickness ≥ 250µm
- HbA1c > 6,5% at initial visit
- BCVA ≤0.8 and ≥0.05
- Age ≥18 years
Key exclusion criteria (7 listed)
- Previous treatment with intravitreal drugs in last 6 months
- Vitreous hemorrhage as a consequence of proliferative retinopathy
- Pregnancy
- Blood pressure of ≥ 180/100 (or uncontrolled pressures under pharmacological therapy)
- Chronic systemic or ocular inflammatory/autoimmune diseases (e.g. inflammatory bowel disease, Addison´s disease, Cushing Syndrome, Uveitis)
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 |
|---|---|---|
| ranibizumabRanibizumab injections will be given for diabetic macular edema. In the experimental arm insulin injections and antihypertensiva will be applied. | Drug | Intensified Glycemic Control, Regular Glycemic Control |
Primary outcome
Difference of Best Corrected Visual Acuity Measured in ETDRS Letters Score Between Month 12 Baseline Visit
Time frame: Baseline to 12 months
Measured by the difference in ETDRS letters score between month 12 and baseline according to internal guideline of Charité department of ophthalmology.
7 secondary outcomes
Number of Treatments With Ranibizumab up to 6, 12, 18 and 24 Months of Treatment
Time frame: Baseline to 12 months
Difference of Best Corrected Visual Acuity Measured in ETDRS Letters Score Between Month 6, 12, 24 and Baseline Visit
Time frame: Baseline to 12 months
Macular Thickness Change at 6, 12, 18 and 24 Months Compared to Baseline
Time frame: Baseline to 12 months
Time to Reach Target HbA1c
Time frame: 24 months
Number of Panretinal Laser Photocoagulation (PRP) Treatments Necessary for Neovascular Complications
Time frame: Baseline to 12 months
Number of Participants With Retinal Detachment, Central Retinal Artery Occlusion, or Endophthalmitis and/or Ocular Adverse Events That Are Related to Treatment
Time frame: Baseline to 12 months
Number of Participants With Abnormal Laboratory Values and/or Adverse Events That Are Related to Treatment
Time frame: Baseline to 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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.
The record lists no contact. Use the official record to reach the sponsor.
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 in people with Visual Acuity Reduced Transiently and Macular Edema, Cystoid, run by Prof. Dr. Antonia M. Joussen at 1 site in Germany.
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 7 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: stopped early, as of the sponsor's last update on 20 Nov 2019. 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 Germany. 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?
Yes. Results are posted in the registry (first posted 20 Nov 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Difference of Best Corrected Visual Acuity Measured in ETDRS Letters Score Between Month 12 Baseline Visit (time frame: Baseline to 12 months). 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 20 Nov 2019.