Wet Age-Related Macular DegenerationPhase 4TIDE AMDNCT02257632
Systemic Vascular Endothelial Growth Factor (VEGF) Protein Dynamics Following Intravitreal Injections of Ranibizumab Versus Aflibercept in Patients With Neovascular Age-related Macular Degeneration
A Phase 4 study testing Ranibizumab 0.5 mg and Aflibercept 2 mg in people with Wet Age-Related Macular Degeneration, run by Novartis Pharmaceuticals at 6 sites in Germany.
Trial summary
The purpose of the study was to compare the effect of intravitreal injections of ranibizumab and aflibercept on systemic VEGF protein levels in treatment naïve wet neovascular Age-related Macular Degeneration (wAMD) 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
- Wet Age-Related Macular Degeneration
- What is being tested?
- Ranibizumab 0.5 mg and Aflibercept 2 mg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 6 sitesGermany
- Study dates
- 8 Apr 2015to 8 Jun 2017
- 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
- Visual impairment predominantly due to neovascular AMD.
- Active, newly diagnosed, untreated, angiographically documented, CNV lesion (i.e. leakage on fluorescein angiography plus intraretinal, subretinal or sub-RPE fluid on OCT) secondary to neovascular AMD in line with SmPC of ranibizumab and aflibercept
Who cannot join
- Stroke or myocardial infarction less than 3 months prior to screening.
- Presence of uncontrolled systolic blood pressure or diastolic blood pressure
- Type 1 or Type 2 diabetes mellitus
- Use of any systemic anti-VEGF drugs
- Use of systemic or inhaled corticosteroids for at least 30 consecutive days within 3 months prior to screening.
- 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
Show all 20Show fewer
- 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, rhegmatogenous retinal detachment, proliferative retinopathy or choroidal neovascularization of any other cause than wAMD
- Irreversible structural damage within 0.5 disc diameter of the center of the macula
- Any intraocular procedure (including cataract surgery, Yttrium-Aluminum-Garnet capsulotomy) within 3 months prior to baseline or anticipated within the next 6 months following baseline.
- Use of intravitreal or topical ocular corticosteroids administered for at least 30 consecutive days within 3 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.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Germany6 sites
Novartis Investigative Site
Cologne, 50924
Novartis Investigative Site
Marburg, 35039
Novartis Investigative Site
München, 80336
Novartis Investigative Site
München, 81675
Novartis Investigative Site
Osnabrück, 49076
Novartis Investigative Site
Regensburg, 93042
About this study
Official title: A Randomized, Single-blinded, Multicenter, Phase IV Study to Compare Systemic VEGF Protein Dynamics Following Monthly Intravitreal Injections of 0.5 mg Ranibizumab Versus 2 mg Aflibercept Until Study Week 12 in Patients With Neovascular (Wet) Age-related Macular Degeneration
The purpose of the study was to compare the effect of intravitreal injections of ranibizumab and aflibercept on systemic VEGF protein levels in treatment naïve wet neovascular Age-related Macular Degeneration (wAMD) patients in a detailed time course.
Read the detailed description
A planned study visit schedule was established at the time of baseline visit (day 1) for all patients. Study assessments for patients were performed at screening visit, baseline (day 1), day 2, day 8 (± 1 day to allow for flexibility in scheduling) and as of day 15 through to day 169 at biweekly visits.
- Conditions
- Wet Age-Related Macular Degeneration
- Being tested
- Ranibizumab 0.5 mg, Aflibercept 2 mg
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ranibizumab 0.5 mgDrug
Also called Lucentis
Administered as an intravitreal injection
Aflibercept 2 mgDrug
Also called Eylea
Administered as an intravitreal injection
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | 6 monthly intravitreal injections of 0.5 mg ranibizumab Receives: Drug: Ranibizumab 0.5 mg |
| Group 2 | Experimental | 3 monthly intravitreal injections of 2 mg aflibercept followed by 3 monthly intravitreal injections of 0.5 mg ranibizumab Receives: Drug: Ranibizumab 0.5 mg; Drug: Aflibercept 2 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Standardized Area Under the Curve (AUC) for VEGF A Levels by SIMOA (Quanterix's Single Molecule Array) Method for the Comparative Phase
The AUC was calculated using the trapezoidal rule, where all available measurement between Day 1 and Week 12 were used. The AUC was standardized by dividing the calculated value by the number of days from first to last measurement.
Measured: Baseline up to Week 12 visit (Days 1, 2, 8, 15, 29, 43, 57, 71, 85)
Secondary outcomes (2)
Systemic VEGF-A Protein Levels From Study Week 12 to 24
Systemic VEGF-A protein levels in patients switching from monthly 2 mg aflibercept injections to monthly 0.5 mg ranibizumab compared to patients treated with monthly 0.5 mg ranibizumab from baseline (standardized area under the curve)
Measured: From study week 12 to 24 (Days 85, 99, 113, 127, 141, 155, 169)
Systemic VEGF-A Levels From Study Week 12 to 24 (Change From Baseline)
Adjustment of systemic VEGF-A levels of patients switching from aflibercept to ranibizumab to levels comparable to baseline or to levels comparable as in patients treated from baseline with ranibizumab
Measured: From study week 12 to 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2014 (estimated)
- Study start8 Apr 2015
- Primary completion20 Mar 2017
- Study completion8 Jun 2017
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 Wet Age-Related Macular DegenerationStudies 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
- 41 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
- NCT02257632
- Sponsor's protocol ID
- CRFB002ADE27
- Acronym
- TIDE AMD
- Status last verified
- Jan 2019
- First submitted
- 2 Oct 2014
- Last updated
- 7 May 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- 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 7 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Single-blinded, Multicenter, Phase IV Study to Compare Systemic VEGF Protein Dynamics Following Monthly Intravitreal Injections of 0.5 mg Ranibizumab Versus 2 mg Aflibercept Until Study Week 12 in Patients With Neovascular (Wet) Age-related Macular Degeneration
- ClinicalTrials.gov ID
- NCT02257632
- Acronym / sponsor ID
- TIDE AMD / CRFB002ADE27
- Conditions
- Wet Age-Related Macular Degeneration
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 8 Apr 2015 (actual)
- Primary completion
- 20 Mar 2017 (actual)
- Study completion
- 8 Jun 2017 (actual)
- First posted
- 6 Oct 2014 (estimated)
- Results
- Posted 7 May 2019
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 was to compare the effect of intravitreal injections of ranibizumab and aflibercept on systemic VEGF protein levels in treatment naïve wet neovascular Age-related Macular Degeneration (wAMD) patients in a detailed time course.
Detailed description
A planned study visit schedule was established at the time of baseline visit (day 1) for all patients. Study assessments for patients were performed at screening visit, baseline (day 1), day 2, day 8 (± 1 day to allow for flexibility in scheduling) and as of day 15 through to day 169 at biweekly visits.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Drug: Ranibizumab 0.5 mg6 monthly intravitreal injections of 0.5 mg ranibizumab |
| Group 2 | Experimental | Drug: Ranibizumab 0.5 mg, Drug: Aflibercept 2 mg3 monthly intravitreal injections of 2 mg aflibercept followed by 3 monthly intravitreal injections of 0.5 mg ranibizumab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Visual impairment predominantly due to neovascular AMD.
- Active, newly diagnosed, untreated, angiographically documented, CNV lesion (i.e. leakage on fluorescein angiography plus intraretinal, subretinal or sub-RPE fluid on OCT) secondary to neovascular AMD in line with SmPC of ranibizumab and aflibercept
Key exclusion criteria (20 listed)
- Stroke or myocardial infarction less than 3 months prior to screening.
- Presence of uncontrolled systolic blood pressure or diastolic blood pressure
- Type 1 or Type 2 diabetes mellitus
- Use of any systemic anti-VEGF drugs
- Use of systemic or inhaled corticosteroids for at least 30 consecutive days within 3 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 |
|---|---|---|
| Ranibizumab 0.5 mgAlso: LucentisAdministered as an intravitreal injection | Drug | Group 1, Group 2 |
| Aflibercept 2 mgAlso: EyleaAdministered as an intravitreal injection | Drug | Group 2 |
Primary outcome
Standardized Area Under the Curve (AUC) for VEGF A Levels by SIMOA (Quanterix's Single Molecule Array) Method for the Comparative Phase
Time frame: Baseline up to Week 12 visit (Days 1, 2, 8, 15, 29, 43, 57, 71, 85)
The AUC was calculated using the trapezoidal rule, where all available measurement between Day 1 and Week 12 were used. The AUC was standardized by dividing the calculated value by the number of days from first to last measurement.
2 secondary outcomes
Systemic VEGF-A Protein Levels From Study Week 12 to 24
Time frame: From study week 12 to 24 (Days 85, 99, 113, 127, 141, 155, 169)
Systemic VEGF-A Levels From Study Week 12 to 24 (Change From Baseline)
Time frame: From study week 12 to 24
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Wet Age-Related Macular Degeneration
Active, not recruitingObservational study
Retinal Pigment Epithelium Safety Study For Patients In B4711001
Age Related Macular Degeneration
Active, not recruitingPhase 3
A Study to Evaluate the Efficacy and Safety of Tarcocimab Tedromer and Tabirafusp Tedromer Compared to Aflibercept in Participants With Neovascular (Wet) Age-related Macular Degeneration (wAMD) - DAYBREAK
Wet Age-related Macular Degeneration
Not yet recruitingPhase 2
A Study to Evaluate the Efficacy and Safety of VIS-101 in Participants With Neovascular Age-Related Macular Degeneration
Neovascular Age Related Macular Degeneration(nAMD)
RecruitingPhase 1
Safety and Efficacy Study of IVB103 Injection in Subjects With Neovascular (Wet) Agerelated Macular Degeneration (nAMD).
nAMD
RecruitingPhase 2
Safety and Efficacy of AIV007 Periocular Injection in Patients With Neovascular Age-Related Macular Degeneration
Neovascular (Wet) Age-Related Macular Degeneration
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
6 sites 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 0.5 mg and Aflibercept 2 mg in people with Wet Age-Related Macular Degeneration, run by Novartis Pharmaceuticals at 6 sites 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 2 inclusion and 20 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 7 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites 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 7 May 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?
Standardized Area Under the Curve (AUC) for VEGF A Levels by SIMOA (Quanterix's Single Molecule Array) Method for the Comparative Phase (time frame: Baseline up to Week 12 visit (Days 1, 2, 8, 15, 29, 43, 57, 71, 85)). 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 7 May 2019.