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Macular DegenerationPhase 4RESPONSENCT01213667

Genetics in Non-response to Anti-VEGF Treatment in Exudative AMD

A Phase 4 study testing Ranibizumab in people with Macular Degeneration, run by University of Cologne at 1 site in Germany.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

To assess genetic features and intraocular cytokine profiles of non-responders to anti-VEGF treatment of exudative age-related macular degeneration. Also to assess necessity and frequency of pro re nate medical re-treatment. Read more about this study

Who is it for?
Ages 60 years and older
Conditions the study is for
Macular Degeneration
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
110 participants
Where
1 siteGermany
Study dates
Jan 2010to Dec 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 60 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • active subfoveal CNV related to exudative age-related macular degeneration (all subforms)
  • age > 60 years
  • visual acuity > 20/400
  • no previous treatment for AMD

Who cannot join

  • any previous AMD therapy
  • other CNV types (myopic, parapapillary)
  • contraindication for ranibizumab treatment
  • prior study participation for AMD
  • pregnancy / premenopausal women

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • University Center of Ophthalmology

    Cologne, North Rhine-Westphalia, 50924

Other trials in Germany

About this study

Official title: Pharmacogenetics in Anti-VEGF Treatment Non-responders Suffering Exudative Age-related Macular Degeneration (AMD): Genetic Correlations and Intraocular Cytokine Concentrations

To assess genetic features and intraocular cytokine profiles of non-responders to anti-VEGF treatment of exudative age-related macular degeneration. Also to assess necessity and frequency of pro re nate medical re-treatment.

Being tested
Ranibizumab
Medical subject headings
Macular Degeneration

What participants receive

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

  • RanibizumabDrug

    Also called Lucentis

    upload (three monthly injections), re-treatment as needed

Study groups in NCT01213667
Study groupRoleWhat they receive
ranibizumab as neededOtherNot described
Receives: Drug: Ranibizumab

What is being measured

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

  1. Visual acuity

    Change in visual acuity within the observation period

    Measured: 2 years

Secondary outcomes (4)

  1. Association between treatment response and genotype

    Measured: 2 years

  2. Changes in OCT central retinal thickness / retinal volume

    Measured: 2 years

  3. Association between treatment application delay and visual outcome

    Measured: 2 years

  4. Association between re-treatment necessity / frequency and intraocular cytokine profiles

    Measured: 2 years

Timeline

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

  1. First posted4 Oct 2010 (estimated)
  2. Study startJan 2010
  3. Primary completionDec 2017 (estimated)
  4. Study completionDec 2017 (estimated)

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
110 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01213667
Sponsor's protocol ID
RESPONSE2010
Acronym
RESPONSE
Status last verified
Oct 2016
First submitted
1 Oct 2010
Last updated
26 Oct 2016
Results posted
No
Data monitoring committee
No

Publications

  • Fauser S, Muether PS. Clinical correlation to differences in ranibizumab and aflibercept vascular endothelial growth factor suppression times. Br J Ophthalmol. 2016 Nov;100(11):1494-1498. doi: 10.1136/bjophthalmol-2015-308264. Epub 2016 Feb 17.

    PubMed 26888975

  • Saunders DJ, Muether PS, Fauser S. A model of the ocular pharmacokinetics involved in the therapy of neovascular age-related macular degeneration with ranibizumab. Br J Ophthalmol. 2015 Nov;99(11):1554-9. doi: 10.1136/bjophthalmol-2015-306771. Epub 2015 May 8.

    PubMed 25957377

  • Koch KR, Muether PS, Hermann MM, Hoerster R, Kirchhof B, Fauser S. Subjective perception versus objective outcome after intravitreal ranibizumab for exudative AMD. Graefes Arch Clin Exp Ophthalmol. 2012 Feb;250(2):201-9. doi: 10.1007/s00417-011-1792-8. Epub 2011 Sep 8.

    PubMed 21901296

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Ranibizumab in people with Macular Degeneration, run by University of Cologne 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 4 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 26 Oct 2016. 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?

Results are not available in the source record.

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?

Visual acuity (time frame: 2 years). 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 NCT01213667, which also lists 3 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 26 Oct 2016.

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