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Functional and Structural Outcomes in Neovascular Age-related Macular Degeneration (CAPTAIN)

Primary Purpose

Neovascular Age-related Macular Degeneration

Status
Completed
Phase
Phase 4
Locations
Germany
Study Type
Interventional
Intervention
Ranibizumab
Sponsored by
Johannes Gutenberg University Mainz
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Neovascular Age-related Macular Degeneration focused on measuring neovascular age-related macular edema, biomarker, ranibizumab, lucentis

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria (patients):

  • 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
  • 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.

Inclusion Criteria (healthy subjects):

  • Male or female
  • Age ≥ 50 years

Exclusion Criteria (patients):

  • 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
  • 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.

Exclusion Criteria (Healthy subjects):

  • 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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Ranibizumab treatment of nAMD patients

healthy subjects

Arm Description

nAMD 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.

Analysis of specific biomarker.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Change in BCVA
Change from Baseline (Visit 1) in BCVA score at Week 24 (visit 7) in the study eye.
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.
Number of ranibizumab injections
Mean number of IVT ranibizumab injections needed up to Week 24 (Visit 7) in the study eye.

Full Information

First Posted
July 21, 2016
Last Updated
November 30, 2017
Sponsor
Johannes Gutenberg University Mainz
Collaborators
Novartis
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1. Study Identification

Unique Protocol Identification Number
NCT02843490
Brief Title
Functional and Structural Outcomes in Neovascular Age-related Macular Degeneration
Acronym
CAPTAIN
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2017
Overall Recruitment Status
Completed
Study Start Date
August 5, 2016 (Actual)
Primary Completion Date
August 17, 2017 (Actual)
Study Completion Date
November 9, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Johannes Gutenberg University Mainz
Collaborators
Novartis

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neovascular Age-related Macular Degeneration
Keywords
neovascular age-related macular edema, biomarker, ranibizumab, lucentis

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
71 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ranibizumab treatment of nAMD patients
Arm Type
Experimental
Arm Description
nAMD 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.
Arm Title
healthy subjects
Arm Type
No Intervention
Arm Description
Analysis of specific biomarker.
Intervention Type
Drug
Intervention Name(s)
Ranibizumab
Other Intervention Name(s)
Lucentis
Intervention Description
Three injections (o.5 mg Ranibizumab) within the first three months is followed by an individual therapy interval based on the clinical progress (PRN)
Primary Outcome Measure Information:
Title
Change in BCVA
Description
Change from Baseline (Visit 1) in BCVA score at Week 12 (visit 4) in the study eye.
Time Frame
Baseline - 12 weeks
Secondary Outcome Measure Information:
Title
Change in BCVA
Description
Change from Baseline (Visit 1) in BCVA score at Week 24 (visit 7) in the study eye.
Time Frame
Baseline - 24 weeks
Title
Change in retinal thickness
Description
Absolute change from baseline (Visit 1) in central retinal thickness, assessed by OCT at Week 24 (Visit 7) in the study eye.
Time Frame
Baseline - 24 weeks
Title
Number of ranibizumab injections
Description
Mean number of IVT ranibizumab injections needed up to Week 24 (Visit 7) in the study eye.
Time Frame
24 weeks
Other Pre-specified Outcome Measures:
Title
Identification of biomarkers against retinal antigens
Description
Identification of antibodies (biomarkers) against retinal antigens (anti cyclophilin B, heat shock protein (HSP) 10, HSP 70) in patients with neovascular AMD treated with ranibizumab and healthy subjects.
Time Frame
24 weeks
Title
Validation of biomarkers
Description
Validation of antibodies (biomarkers) against retinal antigens (anti cyclophilin B, heat shock protein (HSP) 10, HSP 70) in patients with neovascular AMD treated with ranibizumab and healthy subjects found in previous studies.
Time Frame
24 weeks
Title
Correlation of functional and structural parameters
Description
To correlate functional and structural parameters (BCVA and central retinal thickness) with the identified biomarkers to differentiate between initial and deferred responders.
Time Frame
24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria (patients): 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 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. Inclusion Criteria (healthy subjects): Male or female Age ≥ 50 years Exclusion Criteria (patients): 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 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. Exclusion Criteria (Healthy subjects): 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christina Korb, MD
Organizational Affiliation
Johannes Gutenberg-University Mainz, Germany
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clinical Trial Site, Department of Ophthalmology, University Medical Center Johannes Gutenberg University Mainz
City
Mainz
ZIP/Postal Code
55131
Country
Germany

12. IPD Sharing Statement

Plan to Share IPD
No

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Functional and Structural Outcomes in Neovascular Age-related Macular Degeneration

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