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Neovascular Age-related Macular DegenerationPhase 4CAPTAINNCT02843490

Functional and Structural Outcomes in Neovascular Age-related Macular Degeneration

A Phase 4 study testing Ranibizumab in people with Neovascular Age-related Macular Degeneration, run by Johannes Gutenberg University Mainz 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

Several studies during the last years reported the involvement of anti-retinal autoantibodies in ocular disorders, such as AMD. These studies support the growing evidence of an immunological involvement in the pathogenesis of AMD. In the planned trial it is planned to enroll 70 subjects, i.e. Read more about this study

Who is it for?
Ages 50 years and olderHealthy volunteers can take part
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
71 participants
Where
1 siteGermany
Study dates
5 Aug 2016to 9 Nov 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 50 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Male or female
  • Age ≥ 50 years
  • Subfoveal, juxtafoveal and/or extrafoveal choroidal neovascularisation due to neovascular age-related macular degeneration in the study eye
  • Visual acuity of 20/400 (ETDRS charts) or better in the study eye
  • Ability of subject to understand character and individual consequences of clinical Trial
  • Signed and dated informed consent of the subject must be available before start of any specific trial procedures
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  • Women with childbearing potential have to practice a medically accepted contraception during trial and a negative pregnancy test (urine) should be existent before trial. Reliable contraception are systematic contraceptives (oral, implant, injection) and diaphragm or condoms with spermicide. Women that are sterile by surgery or for more than two years postmenopausal can participate in the trial.
  • Male or female
  • Age ≥ 50 years

Who cannot join

  • Inability to obtain fluorescein angiography
  • Ophthalmic Surgery or laser < 3 months before enrolment in one or both eyes
  • Any history of intravitreal steroids in one or both eyes
  • Systemic and/or intravitreal anti-VEGF-treatment < 3 months before enrolment in one or both eyes
  • Patients with hypersensitivity against ranibizumab
  • Ocular inflammation (including trace or above) or external ocular inflammation in the study eye
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  • Inability to give informed consent to participate in the study
  • Pregnancy and lactation; Woman who are of childbearing age and not using medically acceptable effective contraception.
  • Medical or psychological condition that would not permit completion of the trial or signing of informed consent (legal representative accepted)
  • Participation in other clinical trials including an investigational drug or device during the present clinical trial or within the last 4 weeks.
  • Ophthalmic Surgery or laser < 3 months before enrolment
  • Relevant eye diseases except age-related cataract in one or both eyes
  • Inability to give informed consent to participate in the study
  • Pregnancy and lactation; Woman who are of childbearing age and not using medically acceptable effective contraception.
  • Medical or psychological condition that would not permit completion of the trial or signing of informed consent (legal representative accepted)
  • Participation in other clinical trials including an investigational drug or device during the present clinical trial or within the last 4 weeks

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • Clinical Trial Site, Department of Ophthalmology, University Medical Center Johannes Gutenberg University Mainz

    Mainz, 55131

Other trials in Germany

About this study

Official title: Correlation of Functional and Structural Outcomes With Serum Antibody Profiles in Patients With Neovascular Age-related Macular Degeneration Treated With Ranibizumab and Healthy Subjects: A Prospective, Controlled Monocenter Trial

Several studies during the last years reported the involvement of anti-retinal autoantibodies in ocular disorders, such as AMD. These studies support the growing evidence of an immunological involvement in the pathogenesis of AMD. In the planned trial it is planned to enroll 70 subjects, i.e. 50 subjects with neovascular AMD and 20 healthy volunteers. The investigators will evaluate the change from Baseline (Visit 1) in BCVA score at Week 12 (visit 4) in the study eye of nAMD patients treated with Ranibizumab. Neovascular AMD patients (group 1) will be accompanied for 6 months and blood samples will be collected at baseline and monthly until Visit 7 for analysis of antibody profiles. Healthy volunteers (group 2) will be enrolled and a blood sample will be collected once for analysis of antibody profiles. Antibody profiles of all study participants will be analysed to address questions as defined in the outcome measures.

Read the detailed description

Several studies during the last years reported the involvement of anti-retinal autoantibodies in ocular disorders, such as retinal vasculitis, retinopathy, retinitis pigmentosa and also AMD. These studies support the growing evidence of an immunological involvement in the pathogenesis of AMD. In the planned trial it is planned to enroll 70 subjects, i.e. 50 subjects with neovascular AMD and 20 healthy volunteers. The investigators will evaluate the change from Baseline (Visit 1) in BCVA score at Week 12 (visit 4) in the study eye of nAMD patients treated with Ranibizumab. AMD patients and healthy volunteers will be recruited at the Department of Ophthalmology of the University Medical Center, Johannes Gutenberg-University Mainz and included based on defined criteria. Neovascular AMD patients (group 1) will be accompanied for 6 months and blood samples will be collected at baseline and monthly until Visit 7 for analysis of antibody profiles. Ranibizumab is applied according to the manufacturer's recommendations and the "Stellungnahme der DOG, RG und BVA zu aktuellen therapeutischen Möglichkeiten bei der neovaskulären AMD" (December 2012). A loading dose of three injections within the first three months is followed by an individual therapy interval based on the clinical progress (PRN). Re-treatment after the upload of the three initial doses every 4 weeks will be performed in case of progression (PRN) based on the recommendations of the "Stellungnahme der DOG, RG und BVA zu aktuellen therapeutischen Möglichkeiten bei der neovasculären AMD" (December 2012). Healthy volunteers (group 2) will be enrolled and a blood sample will be collected once for analysis of antibody profiles.

Beside the analysis of primary endpoint, the investigators propose to analyze in detail the following questions:

Does the ranibizumab treatment have any effects on antibody profiles found in sera and do these changes correlate with the clinical course of the disease?

Additionally, the patient group can be divided into two subgroups: AMD patients with newly diagnosed neovascular AMD, who have not received anti-VEGF-treatment so far (naïve subjects) and AMD patients with neovascular AMD, who have not received any anti-VEGF treatment 3 months prior to inclusion in the study. This separation may help to answer the question if it is possible to differentiate between ranibizumab responder and non-responder with the help of antibody profiles.

Being tested
Ranibizumab
Keywords
neovascular age-related macular edema, biomarker, ranibizumab, lucentis

What participants receive

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

  • RanibizumabDrug

    Also called Lucentis

    Three injections (o.5 mg Ranibizumab) within the first three months is followed by an individual therapy interval based on the clinical progress (PRN)

Study groups in NCT02843490
Study groupRoleWhat they receive
Ranibizumab treatment of nAMD patientsExperimentalnAMD patients will be treated with Ranibizumab (0.5 mg injection) 3 times within three months followed by individual therapy interval based on the clinical progress (PRN) up to 7 times. Analysis of specific biomarker.
Receives: Drug: Ranibizumab
healthy subjectsNo interventionAnalysis of specific biomarker.

What is being measured

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

  1. Change in BCVA

    Change from Baseline (Visit 1) in BCVA score at Week 12 (visit 4) in the study eye.

    Measured: Baseline - 12 weeks

Secondary outcomes (3)

  1. Change in BCVA

    Change from Baseline (Visit 1) in BCVA score at Week 24 (visit 7) in the study eye.

    Measured: Baseline - 24 weeks

  2. Change in retinal thickness

    Absolute change from baseline (Visit 1) in central retinal thickness, assessed by OCT at Week 24 (Visit 7) in the study eye.

    Measured: Baseline - 24 weeks

  3. Number of ranibizumab injections

    Mean number of IVT ranibizumab injections needed up to Week 24 (Visit 7) in the study eye.

    Measured: 24 weeks

Timeline

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

  1. First posted25 Jul 2016 (estimated)
  2. Study start5 Aug 2016
  3. Primary completion17 Aug 2017
  4. Study completion9 Nov 2017

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
Basic science
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
71 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02843490
Sponsor's protocol ID
469055
Acronym
CAPTAIN
Status last verified
Nov 2017
First submitted
21 Jul 2016
Last updated
2 Dec 2017
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Ranibizumab in people with Neovascular Age-related Macular Degeneration, run by Johannes Gutenberg University Mainz 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 9 inclusion and 16 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 2 Dec 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.

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 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 in BCVA (time frame: Baseline - 12 weeks). 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 NCT02843490.

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 2 Dec 2017; AzTrials last refreshed its copy on 26 Oct 2026.

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