Functional and Structural Outcomes in Neovascular Age-related Macular Degeneration (CAPTAIN)
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|ClinicalTrials.gov Identifier: NCT02843490|
Recruitment Status : Completed
First Posted : July 25, 2016
Last Update Posted : December 2, 2017
|Condition or disease||Intervention/treatment||Phase|
|Neovascular Age-related Macular Degeneration||Drug: Ranibizumab||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||71 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|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|
|Actual Study Start Date :||August 5, 2016|
|Actual Primary Completion Date :||August 17, 2017|
|Actual Study Completion Date :||November 9, 2017|
Experimental: Ranibizumab treatment of nAMD patients
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.
Three injections (o.5 mg Ranibizumab) within the first three months is followed by an individual therapy interval based on the clinical progress (PRN)
Other Name: Lucentis
No Intervention: healthy subjects
Analysis of specific biomarker.
- Change in BCVA [ Time Frame: Baseline - 12 weeks ]Change from Baseline (Visit 1) in BCVA score at Week 12 (visit 4) in the study eye.
- Change in BCVA [ Time Frame: Baseline - 24 weeks ]Change from Baseline (Visit 1) in BCVA score at Week 24 (visit 7) in the study eye.
- Change in retinal thickness [ Time Frame: Baseline - 24 weeks ]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 [ Time Frame: 24 weeks ]Mean number of IVT ranibizumab injections needed up to Week 24 (Visit 7) in the study eye.
- Identification of biomarkers against retinal antigens [ Time Frame: 24 weeks ]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.
- Validation of biomarkers [ Time Frame: 24 weeks ]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.
- Correlation of functional and structural parameters [ Time Frame: 24 weeks ]To correlate functional and structural parameters (BCVA and central retinal thickness) with the identified biomarkers to differentiate between initial and deferred responders.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02843490
|Clinical Trial Site, Department of Ophthalmology, University Medical Center Johannes Gutenberg University Mainz|
|Mainz, Germany, 55131|
|Principal Investigator:||Christina Korb, MD||Johannes Gutenberg-University Mainz, Germany|