Neovascular AMD, Visual Impairment Due to DME, Visual Impairment Due to Macular Oedema Secondary to Branch or Central RVO, Visual Impairment Due to CNVOCEANNCT02194803

Observation of Treatment Patterns With Lucentis in Approved Indications

An observational study of Neovascular AMD, Visual Impairment Due to DME, Visual Impairment Due to Macular Oedema Secondary to Branch or Central RVO, Visual Impairment Due to CNV, run by Novartis Pharmaceuticals at 1 site 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

Who is it for?: Ages 18 years and older
Conditions the study is for: Neovascular AMD, Visual Impairment Due to DME, Visual Impairment Due to Macular Oedema Secondary to Branch or Central RVO, Visual Impairment Due to CNV
How many people: 5,778 participants
Where: 1 siteGermany
Study dates: 8 Dec 2011to 31 Dec 2016
Phase: Observational
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

Study population: Male and female patients suffering from neovascular eye pathology in real life setting for whom a therapy with Lucentis® is recommended by the treating physician in line with approved indications. Warnings and contraindications have to be taken into account according to the summary of product characteristics (SmPC).

Who may be able to join

Presence of
neovascular (wet) age-related macular degeneration (AMD),
visual impairment due to diabetic macular oedema (DME),
visual impairment due to macular oedema secondary to retinal vein occlusion (branch RVO or central RVO) or
visual impairment due to choroidal neovascularisation (CNV) secondary to pathologic myopia (PM)
Patients for whom a therapy with Lucentis® is medically indicated.
Written patients informed consent.

Who cannot join

As described in the SmPC.
Preceding intravitreal treatment of the study eye with anti-VEGF drugs in the last three months before enrollment
Preceding intravitreal treatment of the study eye with steroids

Trial locations and contacts

1 site in 1 country.

Germany1 site

Novartis Investigative Site
Tübingen, 72076

Other trials in Germany

About this study

Official title: Observation of Treatment Patterns With Lucentis and Real Life Ophthalmic Monitoring, Including Optional OCT in Approved Indications

A multicentre, open-label, non-interventional study to observe treatment patterns in patients with wet age-related macular degeneration (wAMD), with visual impairment due to diabetic macular edema (DME), due to macular edema following retinal vein occlusion (RVO) or due to chorioidal neovascularization following pathologic myopia (mCNV) with repeated intravitreal injections of Lucentis® (Ranibizumab) including optional OCT monitoring over a 24 months observational period under real life conditions.

Conditions: Neovascular AMD, Visual Impairment Due to DME, Visual Impairment Due to Macular Oedema Secondary to Branch or Central RVO, Visual Impairment Due to CNV

What participants receive

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

Study groups in NCT02194803
Study group	Role	What they receive
Cohort with routine OCT monitoring		Not described
Cohort without routine OCT monitoring		Not described

What is being measured

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

Change from Baseline in Visual Acuity (VA) to Month 12
Visual Acuity is measured either with ETDRS Scores, Snellen or decimal Scale according to routine clinical practice. Measurements are transferred to LogMAR for statistical analysis. LogMAR is defined as logarithm of the minimum angle of resolution.
Measured: Baseline, Month 12
Change from Baseline in Visual Acuity (VA) to Month 24
Visual Acuity is measured either with ETDRS Scores, Snellen or decimal Scale according to routine clinical practice. Measurements are transferred to LogMAR for statistical analysis. LogMAR is defined as logarithm of the minimum angle of resolution.
Measured: Baseline, Month 24

Timeline

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

8 Dec 201131 Dec 2016

First posted18 Jul 2014 (estimated)
Study start8 Dec 2011
Primary completion31 Dec 2016
Study completion31 Dec 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (5)Papers the sponsor has linked to this study.
Other trials for Neovascular AMD, Visual Impairment Due to DME, Visual Impairment Due to Macular Oedema Secondary to Branch or Central RVO, Visual Impairment Due to CNVStudies 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: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 5,778 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02194803
Sponsor's protocol ID: CRFB002ADE18
Acronym: OCEAN
Status last verified: Feb 2017
First submitted: 11 Jun 2014
Last updated: 1 Mar 2017
Results posted: No
Data monitoring committee: No

Publications

Spital G, Schmitz-Valckenberg S, Muller B, Liczenczias E, Chang P, Heimes-Bussmann B, Ziemssen F, Liakopoulos S; ORCA study group. Interpretation of SD-OCT imaging data in real-life conditions versus standardized reading centre analysis in eyes with diabetic macular oedema or macular oedema secondary to retinal vein occlusion: 24-month follow-up of the ORCA study. Graefes Arch Clin Exp Ophthalmol. 2025 Jan;263(1):131-139. doi: 10.1007/s00417-024-06579-7. Epub 2024 Sep 19.
PubMed 39294392
Liakopoulos S, Spital G, Brinkmann CK, Schick T, Ziemssen F, Voegeler J, Koch M, Kirchhof B, Holz FG, Pauleikhoff D, Schmitz-Valckenberg S. ORCA study: real-world versus reading centre assessment of disease activity of neovascular age-related macular degeneration (nAMD). Br J Ophthalmol. 2020 Nov;104(11):1573-1578. doi: 10.1136/bjophthalmol-2019-315717. Epub 2020 Feb 17.
PubMed 32066561
Ziemssen F, Wachtlin J, Kuehlewein L, Gamulescu MA, Bertelmann T, Feucht N, Voegeler J, Koch M, Liakopoulos S, Schmitz-Valckenberg S, Spital G; OCEAN study group. Intravitreal Ranibizumab Therapy for Diabetic Macular Edema in Routine Practice: Two-Year Real-Life Data from a Non-interventional, Multicenter Study in Germany. Diabetes Ther. 2018 Dec;9(6):2271-2289. doi: 10.1007/s13300-018-0513-2. Epub 2018 Oct 4.
PubMed 30288700
Ziemssen F, Feltgen N, Holz FG, Guthoff R, Ringwald A, Bertelmann T, Wiedon A, Korb C; OCEAN study group. Demographics of patients receiving Intravitreal anti-VEGF treatment in real-world practice: healthcare research data versus randomized controlled trials. BMC Ophthalmol. 2017 Jan 19;17(1):7. doi: 10.1186/s12886-017-0401-y.
PubMed 28103831
Ziemssen F, Bertelmann T, Hufenbach U, Scheffler M, Liakopoulos S, Schmitz-Valckenberg S. [Delayed treatment initiation of more than 2 weeks. Relevance for possible gain of visual acuity after anti-VEGF therapy under real life conditions (interim analysis of the prospective OCEAN study)]. Ophthalmologe. 2016 Feb;113(2):143-51. doi: 10.1007/s00347-015-0099-2. German.
PubMed 26201460

Study at a glance

From the registry record, last updated by the sponsor on 1 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Observation of Treatment Patterns With Lucentis and Real Life Ophthalmic Monitoring, Including Optional OCT in Approved Indications
ClinicalTrials.gov ID: NCT02194803
Acronym / sponsor ID: OCEAN / CRFB002ADE18
Conditions: Neovascular AMD, Visual Impairment Due to DME, Visual Impairment Due to Macular Oedema Secondary to Branch or Central RVO, Visual Impairment Due to CNV
Study type: Observational
Recruitment status: Completed
Enrolment: 5,778 participants (actual)
Lead sponsor: Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
Study start: 8 Dec 2011 (actual)
Primary completion: 31 Dec 2016 (actual)
Study completion: 31 Dec 2016 (actual)
First posted: 18 Jul 2014 (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.

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 2

Arm	Type	Receives
Cohort with routine OCT monitoring	–	–
Cohort without routine OCT monitoring	–	–

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Male and female patients suffering from neovascular eye pathology in real life setting for whom a therapy with Lucentis® is recommended by the treating physician in line with approved indications. Warnings and contraindications have to be taken into account according to the summary of product characteristics (SmPC).

Key inclusion criteria (7 listed)

Presence of
Patients for whom a therapy with Lucentis® is medically indicated.
Written patients informed consent.

Key exclusion criteria (3 listed)

As described in the SmPC.
Preceding intravitreal treatment of the study eye with anti-VEGF drugs in the last three months before enrollment
Preceding intravitreal treatment of the study eye with steroids

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

Change from Baseline in Visual Acuity (VA) to Month 12
Time frame: Baseline, Month 12
Visual Acuity is measured either with ETDRS Scores, Snellen or decimal Scale according to routine clinical practice. Measurements are transferred to LogMAR for statistical analysis. LogMAR is defined as logarithm of the minimum angle of resolution.
Change from Baseline in Visual Acuity (VA) to Month 24
Time frame: Baseline, Month 24
Visual Acuity is measured either with ETDRS Scores, Snellen or decimal Scale according to routine clinical practice. Measurements are transferred to LogMAR for statistical analysis. LogMAR is defined as logarithm of the minimum angle of resolution.

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2017.
Derived from this study: PubMed 39294392Spital G, Schmitz-Valckenberg S, Muller B, Liczenczias E, Chang P, Heimes-Bussmann B, Ziemssen F, Liakopoulos S; ORCA study group. Interpretation of SD-OCT imaging data in real-life conditions versus standardized reading centre analysis in eyes with diabetic macular oedema or macular oedema secondary to retinal vein occlusion: 24-month follow-up of the ORCA study. Graefes Arch Clin Exp Ophthalmol. 2025 Jan;263(1):131-139. doi: 10.1007/s00417-024-06579-7. Epub 2024 Sep 19.
Derived from this study: PubMed 32066561Liakopoulos S, Spital G, Brinkmann CK, Schick T, Ziemssen F, Voegeler J, Koch M, Kirchhof B, Holz FG, Pauleikhoff D, Schmitz-Valckenberg S. ORCA study: real-world versus reading centre assessment of disease activity of neovascular age-related macular degeneration (nAMD). Br J Ophthalmol. 2020 Nov;104(11):1573-1578. doi: 10.1136/bjophthalmol-2019-315717. Epub 2020 Feb 17.
Derived from this study: PubMed 30288700Ziemssen F, Wachtlin J, Kuehlewein L, Gamulescu MA, Bertelmann T, Feucht N, Voegeler J, Koch M, Liakopoulos S, Schmitz-Valckenberg S, Spital G; OCEAN study group. Intravitreal Ranibizumab Therapy for Diabetic Macular Edema in Routine Practice: Two-Year Real-Life Data from a Non-interventional, Multicenter Study in Germany. Diabetes Ther. 2018 Dec;9(6):2271-2289. doi: 10.1007/s13300-018-0513-2. Epub 2018 Oct 4.
Derived from this study: PubMed 28103831Ziemssen F, Feltgen N, Holz FG, Guthoff R, Ringwald A, Bertelmann T, Wiedon A, Korb C; OCEAN study group. Demographics of patients receiving Intravitreal anti-VEGF treatment in real-world practice: healthcare research data versus randomized controlled trials. BMC Ophthalmol. 2017 Jan 19;17(1):7. doi: 10.1186/s12886-017-0401-y.
Derived from this study: PubMed 26201460Ziemssen F, Bertelmann T, Hufenbach U, Scheffler M, Liakopoulos S, Schmitz-Valckenberg S. [Delayed treatment initiation of more than 2 weeks. Relevance for possible gain of visual acuity after anti-VEGF therapy under real life conditions (interim analysis of the prospective OCEAN study)]. Ophthalmologe. 2016 Feb;113(2):143-51. doi: 10.1007/s00347-015-0099-2. German.

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

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 7 inclusion and 3 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 1 Mar 2017. 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.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Change from Baseline in Visual Acuity (VA) to Month 12 (time frame: Baseline, Month 12). 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?

On the ClinicalTrials.gov record for NCT02194803, which also lists 5 linked publications.

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 1 Mar 2017; AzTrials last refreshed its copy on 6 Nov 2026.