Visual Impairment Due to Diabetic Macular EdemaPhase 4TIDE DMENCT02878681
24 Week Study to Compare Systemic VEGF-levels of Ranibizumab and Aflibercept in DME.
A Phase 4 study testing Ranibizumab and Aflibercept in people with Visual Impairment Due to Diabetic Macular Edema, run by Novartis Pharmaceuticals.
Trial summary
The purpose of the study is to compare the effect of intravitreal injections of ranibizumab and aflibercept on systemic VEGF levels in DME patients in a detailed time course. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Visual Impairment Due to Diabetic Macular Edema
- What is being tested?
- Ranibizumab and Aflibercept
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Sep 2016to Sep 2017
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Type 1 or Type 2 diabetes mellitus
- Visual impairment due to DME
- BCVA of 78 to 24 (20/32-20/320) ETDRS letters
Who cannot join
- Stroke or myocardial infarction less than 3 months prior to screening.
- Presence of uncontrolled systolic blood pressure or diastolic blood pressure
- Renal failure requiring dialysis or renal transplant or renal insufficiency
- Untreated diabetes mellitus
- Use of any systemic anti-VEGF drugs within 6 months prior to screening.
- Use of systemic or inhaled corticosteroids for at least 30 consecutive days within 3 months prior to screening.
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- Women who are pregnant or breast feeding or who are menstruating and capable of becoming pregnant* and not practicing a medically approved method of contraception
- For either eye:
- Any active periocular or ocular infection or inflammation
- Uncontrolled glaucoma
- Neovascularization of the iris or neovascular glaucoma
- History of treatment with any anti-angiogenic drugs
- For study eye:
- Atrophy or fibrosis involving the center of the fovea at the time of screening or baseline.
- Cataract (if causing significant visual impairment), planned cataract surgery during the study period, vitrectomy, aphakia, glaucoma surgery, severe vitreous hemorrhage, rhegm
- Irreversible structural damage within 0.5 disc diameter of the center of the macula
- Panretinal laser photocoagulation within 6 months prior to randomization.
- Focal/grid laser photocoagulation within 3 months prior to randomization.
- Any intraocular procedure (including cataract surgery, Yttrium-Aluminum-Garnet capsulotomy) within 3 months prior to baseline or anticipated within the next 6 months following
- Topical ocular corticosteroids administered for at least 30 consecutive days within 3 months prior to screening.
- Application of intravitreal corticosteroids in vitreous within 6 months prior to screening. Prior application of fluocinolonacetonid releasing implant in vitreous within 36 months prior to screening.
- For fellow eye
- Retinal or choroidal neovascularization or macula edema of any cause Other protocol-defined inclusion/exclusion criteria may apply.
About this study
Official title: A 24-week, Randomized, Single-masked, Multicenter, Phase IV Study to Compare sysTemic VEGF Levels Following Monthly Intravitreal Injections of 0.5 mg Ranibizumab Versus 2 mg Aflibercept Until Week 24 in Patients With Visual Impairment DuE to Diabetic Macular Edema (TIDE DME).
The purpose of the study is to compare the effect of intravitreal injections of ranibizumab and aflibercept on systemic VEGF levels in DME patients in a detailed time course.
Read the detailed description
The purpose of the study is to compare the effect of monthly intravitreal injections of 0.5 mg ranibizumab and 2.0 mg aflibercept on systemic VEGF levels in patients with visual impairment due to DME over a 24 week period. In addition, the study will also assess the effect on systemic VEGF-A levels when patients are switched from aflibercept to ranibizumab.
- Being tested
- Ranibizumab, Aflibercept
- Keywords
- Diabetic Macular Edema.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RanibizumabDrug
Also called Lucentis
0.5 mg intravitreal injections
AfliberceptDrug
Also called Eylea
2 mg intravitreal injections
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | Monthly intravitreal injections of 0.5 mg ranibizumab for six months Receives: Drug: Ranibizumab |
| Group 2 | Experimental | Monthly intravitreal injections of 2 mg aflibercept for the initial three months followed by monthly intravitreal injections of 0.5 mg ranibizumab for the next three months. Receives: Drug: Ranibizumab; Drug: Aflibercept |
| Group 3 | Experimental | Monthly injections of 2 mg aflibercept for six months Receives: Drug: Aflibercept |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the curve (AUC) of VEGF-A levels from baseline to week 24
Systemic VEGF-A levels following monthly intravitreal injections of 0.5 mg ranibizumab versus 2 mg aflibercept (Area under the curve) expressed in pg/ml*days. The AUC will be standardized (=divided) by the individual follow-up time and will be calculated by the trapezoidal rule..
Measured: baseline to week 24
Secondary outcomes (3)
Mean Systemic VEGF-A levels in serum for patients in treatment group 1 and treatment group 2 within specific time points
To compare systemic VEGF-A levels (pg/ml) in patients switching from monthly 2 mg aflibercept injections for first three months to monthly 0.5 mg ranibizumab (treatment group 2) for the next three months compared to patients treated with monthly 0.5 mg ranibizumab (treatment group 1) for six months at specific time points from week 12 to week 24. The comparison will be performed at specific time points between week 12 and week 24, based on the blood samples collected for visits 10 to 16.
Measured: Day 7, Day 15, Week 4, week 8, week 12, week 14, week 16, week 18, week 20, week 24
Mean Systemic VEGF-A levels in serum for patients in treatment group 1 and treatment group 3 within specific time points
To compare systemic VEGF-A levels (pg/ml) in patients switching from monthly 2 mg aflibercept injections for first three months to monthly 0.5 mg ranibizumab (treatment group 2) for the next three months compared to patients treated with monthly 2 mg aflibercept (treatment group 3) for six months at specific time points from week 12 to week 24. The comparison will be performed at specific time points between week 12 and week 24, based on the blood samples collected for visits 10 to 16.
Measured: Day 7, Day 15, Week 4, week 8, week 12, week 14, week 16, week 18, week 20, week 24
Proportion of patients reporting ocular and/or systemic adverse events in all the three treatment groups.
To evaluate ocular and systemic safety in all the three treatment groups. Only treatment-emergent AEs will be summarized.
AEs will be summarized by presenting for each treatment group the number and percentage of patients having any AE, having an eye-related AEs, having an AE in each primary system organ class and having each individual AEs based on the preferred term. All other information collected (e.g., severity or relationship to study treatment) will be tabulated and listed as appropriate. Summary tables will also be presented for the subset of AEs suspected to be treatment related.
Measured: From Baseline to Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2016 (estimated)
- Study startSep 2016 (estimated)
- Primary completionSep 2017 (estimated)
- Study completionSep 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Visual Impairment Due to Diabetic Macular EdemaStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02878681
- Sponsor's protocol ID
- CRFB002D2404
- Acronym
- TIDE DME
- Status last verified
- Apr 2017
- First submitted
- 22 Jul 2016
- Last updated
- 28 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 24-week, Randomized, Single-masked, Multicenter, Phase IV Study to Compare sysTemic VEGF Levels Following Monthly Intravitreal Injections of 0.5 mg Ranibizumab Versus 2 mg Aflibercept Until Week 24 in Patients With Visual Impairment DuE to Diabetic Macular Edema (TIDE DME).
- ClinicalTrials.gov ID
- NCT02878681
- Acronym / sponsor ID
- TIDE DME / CRFB002D2404
- Keywords
- Diabetic Macular Edema.
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Sep 2016 (estimated)
- Primary completion
- Sep 2017 (estimated)
- Study completion
- Sep 2017 (estimated)
- First posted
- 25 Aug 2016 (estimated)
- 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 purpose of the study is to compare the effect of intravitreal injections of ranibizumab and aflibercept on systemic VEGF levels in DME patients in a detailed time course.
Detailed description
The purpose of the study is to compare the effect of monthly intravitreal injections of 0.5 mg ranibizumab and 2.0 mg aflibercept on systemic VEGF levels in patients with visual impairment due to DME over a 24 week period. In addition, the study will also assess the effect on systemic VEGF-A levels when patients are switched from aflibercept to ranibizumab.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Drug: RanibizumabMonthly intravitreal injections of 0.5 mg ranibizumab for six months |
| Group 2 | Experimental | Drug: Ranibizumab, Drug: AfliberceptMonthly intravitreal injections of 2 mg aflibercept for the initial three months followed by monthly intravitreal injections of 0.5 mg ranibizumab for the next three months. |
| Group 3 | Experimental | Drug: AfliberceptMonthly injections of 2 mg aflibercept for six months |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Type 1 or Type 2 diabetes mellitus
- Visual impairment due to DME
- BCVA of 78 to 24 (20/32-20/320) ETDRS letters
Key exclusion criteria (23 listed)
- Stroke or myocardial infarction less than 3 months prior to screening.
- Presence of uncontrolled systolic blood pressure or diastolic blood pressure
- Renal failure requiring dialysis or renal transplant or renal insufficiency
- Untreated diabetes mellitus
- Use of any systemic anti-VEGF drugs within 6 months prior to screening.
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 |
|---|---|---|
| RanibizumabAlso: Lucentis0.5 mg intravitreal injections | Drug | Group 1, Group 2 |
| AfliberceptAlso: Eylea2 mg intravitreal injections | Drug | Group 2, Group 3 |
Primary outcome
Area under the curve (AUC) of VEGF-A levels from baseline to week 24
Time frame: baseline to week 24
Systemic VEGF-A levels following monthly intravitreal injections of 0.5 mg ranibizumab versus 2 mg aflibercept (Area under the curve) expressed in pg/ml*days. The AUC will be standardized (=divided) by the individual follow-up time and will be calculated by the trapezoidal rule..
3 secondary outcomes
Mean Systemic VEGF-A levels in serum for patients in treatment group 1 and treatment group 2 within specific time points
Time frame: Day 7, Day 15, Week 4, week 8, week 12, week 14, week 16, week 18, week 20, week 24
Mean Systemic VEGF-A levels in serum for patients in treatment group 1 and treatment group 3 within specific time points
Time frame: Day 7, Day 15, Week 4, week 8, week 12, week 14, week 16, week 18, week 20, week 24
Proportion of patients reporting ocular and/or systemic adverse events in all the three treatment groups.
Time frame: From Baseline to Week 24
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2017.
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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.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ranibizumab and Aflibercept in people with Visual Impairment Due to Diabetic Macular Edema, run by Novartis Pharmaceuticals.
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 23 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: withdrawn, as of the sponsor's last update on 28 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
Area under the curve (AUC) of VEGF-A levels from baseline to week 24 (time frame: baseline to week 24). 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 28 Apr 2017.