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Retinal Vein OcclusionPhase 4NCT01580020

Extension Study to Compare Long-term Efficacy and Safety of Ranibizumab Intravitreal Injections Versus Dexamethasone Intravitreal Implant in Patients With RVO

A Phase 4 study testing RFB002 and Dexamethasone in people with Retinal Vein Occlusion, run by Novartis Pharmaceuticals at 37 sites in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The study is intended to characterize the clinical benefit regarding safety and efficacy of a long term treatment with Lucentis in comparison with Ozurdex over an additional 6 months and a 3-month follow-up period, following the initial 6-month treatment in the respective core studies CRFB002EDE17 (NCT01396057) and… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Retinal Vein Occlusion
What is being tested?
RFB002 and Dexamethasone
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
175 participants
Where
37 sitesGermany
Study dates
May 2012to Oct 2014
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 must have completed the core study assessments at month 6 of study CRFB002EDE17 or CRFB002EDE18, respectively

Who cannot join

  • Patients who experienced an uncontrollable rise in IOP during the core study CRFB002EDE17 respectively CRFB002EDE18, i.e. IOP could not be decreased to a stable level of < 25mmHg.
  • Use of other investigational drugs
  • Current use or likely need of systemic medications known to be toxic to the lens, retina or optic nerve
  • History of hypersensitivity to Ranibizumab or Ozurdex or any component of the ranibizumab respectively Ozurdey formulation
  • Any type of advanced, severe or unstable disease or its treatment, that could interfere with evaluations or put the patient at special risk
  • Women
Show all 17Show fewer
  • who were pregnant or breast feeding (pregnancy defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test (>5 mIU/mL)
  • who were menstruating and capable of becoming pregnant* and not practicing a medically approved method of contraception (Pearl Index <1)* during and up to at least 4 weeks after the end of treatment. A negative pregnancy test (serum) for all women and for girls entering menarche was required with sufficient lead time before randomization
  • definition of post-menopausal: 12 months of natural (spontaneous) amenorrhea or 6 months of spontaneous amenorrhea with serum FSH levels >40 mIU/mL or 6 weeks post surgical bilateral oophorectomy with or without hysterectomy
  • examples of particularly reliable methods with Pearl Index (PI) <1, according to guidelines of "Deutsche Gesellschaft für Gynäkologie und Geburtshilfe":
  • Combination pill with estrogen and gestagen (no mini-pill, PI=0.1-0.9)
  • Vaginal ring (NuvaRing®, PI=0.65 uncorr.; 0.4 corr.)
  • Contraceptive patch (EVRA®, PI= 0.72 uncorr.; 0.9 corr.)
  • Estrogen-free ovulation inhibitors (Cerazette®, PI=0.14)
  • Progestin-containing contraceptives (Implanon®, PI=0-0.08)
  • Injectable 3-month depot progestins (PI=0.3-1.4; 0.88 corr.)
  • Intra-uterine progestin device (Mirena®, PI=0.16)

Trial locations and contacts

37 sites in 1 country.

37 sites in 1 country

Germany37 sites

  • Novartis Investigative Site

    Augsburg, 85155

  • Novartis Investigative Site

    Bad Rothenfelde, 49214

  • Novartis Investigative Site

    Berlin, 10713

  • Novartis Investigative Site

    Berlin, 13353

  • Novartis Investigative Site

    Bonn, 53127

  • Novartis Investigative Site

    Bremen, 28209

  • Novartis Investigative Site

    Chemnitz, 09113

  • Novartis Investigative Site

    Cologne, 50935

  • Novartis Investigative Site

    Darmstadt, 64297

  • Novartis Investigative Site

    Dresden, 01307

  • Novartis Investigative Site

    Düsseldorf, 40212

  • Novartis Investigative Site

    Düsseldorf, 40225

  • Novartis Investigative Site

    Frankfurt, 60318

  • Novartis Investigative Site

    Freiburg I. Br, 79106

  • Novartis Investigative Site

    Glauchau, 08371

  • Novartis Investigative Site

    Göttingen, 37075

  • Novartis Investigative Site

    Halle, 06114

  • Novartis Investigative Site

    Hamburg, 20246

  • Novartis Investigative Site

    Ingolstadt, 85049

  • Novartis Investigative Site

    Karlsruhe, 76133

  • Novartis Investigative Site

    Karlsruhe, 76199

  • Novartis Investigative Site

    Leipzig, Germany, 04103

  • Novartis Investigative Site

    Ludwigshafen, 67063

  • Novartis Investigative Site

    Marburg, 35039

  • Novartis Investigative Site

    Minden, 32427

  • Novartis Investigative Site

    Mülheim, 45468

  • Novartis Investigative Site

    München, 80336

  • Novartis Investigative Site

    München, 81675

  • Novartis Investigative Site

    Münster, 48145

  • Novartis Investigative Site

    Münster, 48149

  • Novartis Investigative Site

    Recklinghausen, 45657

  • Novartis Investigative Site

    Regensburg, Germany, 93042

  • Novartis Investigative Site

    Sulzbach, 66280

  • Novartis Investigative Site

    Tübingen, 72076

  • Novartis Investigative Site

    Ulm, 89075

  • Novartis Investigative Site

    Wolfsburg, 38442

  • Novartis Investigative Site

    Würzburg, 97080

Other trials in Germany

About this study

Official title: An Open-label, Multi-center, 6-month Extension Study Comparing the Long-term Efficacy and Safety of Lucentis (Ranibizumab) Intravitreal Injections Versus Ozurdex (Dexamethasone) Intravitreal Implant in Patients With Visual Impairment Due to Macular Edema Following Branch Retinal Vein Occlusion (BRVO) or Central Retinal Vein Occlusion (CRVO) Who Have Completed the Respective Core Study (CRFB002EDE17 or CRFB002EDE18)

The study is intended to characterize the clinical benefit regarding safety and efficacy of a long term treatment with Lucentis in comparison with Ozurdex over an additional 6 months and a 3-month follow-up period, following the initial 6-month treatment in the respective core studies CRFB002EDE17 (NCT01396057) and CRFB002EDE18 (NCT01396083).

Being tested
RFB002, Dexamethasone
Keywords
Macular Degeneration, Macular Edema, Retinal Vein Occlusion, Choroidal Neovascularization, Signs and Symptoms, Retinal Degeneration, Retinal Diseases, Eye Diseases, Venous Thrombosis Sensation Disorders, Dexamethasone acetate, Dexamethasone, Dexamethasone 21-phosphate, BB 1101, Anti-Inflammatory Agents, Therapeutic Uses, Vision, Low, Signs, Vision Disorders
Medical subject headings
Retinal Vein Occlusion, Macular Degeneration, Macular Edema, Choroidal Neovascularization, Signs and Symptoms, Retinal Degeneration, Retinal Diseases, Eye Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RFB002Biological

    0.5 mg/0.05 mL solution to be injected intravitreally. Ranibizumab was formulated as a sterile solution aseptically filled in a sterile glass vial. Each vial contained ranibizumab in an aqueous solution (pH 5.5) with histidine, trehalose and polysorbate 20.

  • DexamethasoneDrug

    Ozurdex (Dexamethasone): intravitreal implant as per commercial label (700 µg Dexamethasone; Dexamethasone was formulated as a rod shaped implant to be inserted into the eye by an applicator. The implant as well as the respective applicator were suitable for single use only. Dexamethasone had to be stored according to label instructions and it had to be kept in a secure locked facility

Study groups in NCT01580020
Study groupRoleWhat they receive
Ranibizumab (Arm A)ExperimentalThe PRN injection scheme applied in the core study will also be followed during this extension study: Patients should be monitored monthly (starting at V1E) for VA and treatment is to be resumed when monitoring indicates loss of VA due to disease activity. Monthly injections should then be administered until stable VA is reached again for 3 consecutive monthly assessments (implying a minimum of 2 injections during stable VA). The interval between 2 doses should not be shorter than 1 month
Receives: Biological: RFB002
Dexamethasone (Arm B)Sham comparatorA PRN re-treatment scheme will be applied for the Ozurdex arm during this extension study, i.e. patients may receive an implant at V1E or later as needed: Patients should be monitored monthly and if there is a decline from stable VA stability due to macular edema patients will receive another intravitreal implant. (700 µg; long acting release (LAR)) given that in the opinion of the investigator the patient would benefit from the re-treatment. However, a minimum period of 5 months in between implantations is required.
Receives: Drug: Dexamethasone

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants With Adverse Events as a Measure of Safety and Tolerability

    The number of participants who experienced Adverse events, serious AE and death

    Measured: 6 months

Secondary outcomes (8)

  1. Raw Mean Best Corrected Visual Acuity (BCVA) by Treatment Group

    Best-Corrected Visual Acuity (BCVA) letters was measured using Early Treatment Diabetic Retinopathy Study (EDTRS)-like chart while participants were in a sitting position at a testing distance of 4 meters. An ETDRS visual acuity score of 85 is approximately 20/20. The range of BCVA (EDTRS) is 0 to 100 letters. A positive change from baseline of BCVA indicates improvement

    Measured: Baseline, 6 months and 12 months

  2. Percentage of Patients Gaining / Losing ≥ 15 / 10 / 5 Letters at Month 12 Compared to Baseline

    BCVA score was based on the number of letters read correctly on the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart assessed at a starting distance of 4 meters. An ETDRS visual acuity score of 85 is approximately 20/20. An increased score indicates improvement in acuity. This outcome assessed the percentage of participants who were gaining/losing ≥15, 10 or 5 more letters of visual acuity at month 12 as compared with baseline

    Measured: 12 month

  3. Change in Central Subfield Thickness (CSRT) From Baseline to Month 12

    High Resolution OCT was performed at every study visit by Spectral Domain OCT (if not available Time Domain OCT was acceptable) and the images were transferred to a digital video disc. These assessments were performed by trained and adequately qualified experts at the sites and prior to any study drug administration. CSFT is the average retinal thickness of the circular area with 1 mm diameter around the foveal center.

    Measured: Baseline , Month 12

  4. Change of Foveal Center Point Thickness (FCPT) From Baseline to Month 12

    FCPT (foveal center point thickness) was assessed by central reading center to ensure error- corrected measurements of retinal thickness and volumes,

    Measured: Baseline, Month 12

  5. Change in Mean Visual Function Questionnaire (VFQ-25)

    The VFQ-25 composite and subscale scores range from 0 to 100, a higher score indicating better functioning. The 12 subscales in the VFQ-25 are general health, general vision, ocular pain, near activities, distance activities, social function, mental health, role difficulties, dependency, driving, color vision, and peripheral vision. The scores on the subscales were added together for a total score, which ranged from 0 to 100. A higher score indicated improvement in quality of life due to vision function.

    Measured: Baseline, 12 months

  6. Change in SF-36 Summary Scores

    The SF-36 measures the impact of disease on overall quality of life and consists of eight subscales (physical function, pain, general and mental health, vitality, social function, physical and emotional health) which can be aggregated to derive a physical-component summary score and a mental-component summary score. Scores for each subscale range from 0 to 10, and the composite scores range from 0 to 100, with higher scores indicating better health. A positive change from Baseline score indicates improvement in quality of life.

    Measured: Baseline, month 12

  7. Change in Euro Quality of Life Questionnaire (EQ-5D) VAS Summary Scores

    The Euro Quality of Life Questionnaire (EQ-5D) standardized instrument was utilized to measure health outcomes related to mobility, self care, usual activities, pain/discomfort, and anxiety/depression. Participants self-rate their health on a visual, vertical analogue scale from 0 to 100 where the endpoints are labeled "Best imaginable health state" (100) and "worst imaginable health state" (0).

    Measured: Baseline, month 12

  8. Time to the First Retreatment of Both Treatment Arms

    Time to the first retreatment

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Apr 2012 (estimated)
  2. Study startMay 2012
  3. Primary completionOct 2014
  4. Study completionOct 2014

Resources

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
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
175 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01580020
Sponsor's protocol ID
CRFB002EDE20
Other IDs
2011-005045-13
Status last verified
Apr 2016
First submitted
16 Apr 2012
Last updated
17 May 2016
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing RFB002 and Dexamethasone in people with Retinal Vein Occlusion, run by Novartis Pharmaceuticals at 37 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 1 inclusion and 17 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 17 May 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 37 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. Some participants in this study may receive a placebo. 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 17 May 2016). 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?

Number of Participants With Adverse Events as a Measure of Safety and Tolerability (time frame: 6 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 NCT01580020.

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 17 May 2016; AzTrials last refreshed its copy on 1 Nov 2026.

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