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NCT02843490: CAPTAIN
Functional and Structural Outcomes in Neovascular Age-related Macular Degeneration
Phase 4 trial testing Ranibizumab in Neovascular Age-related Macular Degeneration in 71 participants. Completed in 9 November 2017.
17 August 2017
Quick facts
| Lead sponsor | Johannes Gutenberg University Mainz |
|---|---|
| Phase | Phase 4 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | basic science |
| Enrollment | 71 |
| Start date | 5 August 2016 |
| Primary completion | 17 August 2017 |
| Estimated completion | 9 November 2017 |
| Sites | 1 location across Germany |
Drugs / interventions tested
- Ranibizumab — full drug profile →
Conditions studied
- Neovascular Age-related Macular Degeneration — all drugs for Neovascular Age-related Macular Degeneration →
Sponsor
Johannes Gutenberg University Mainz
Who can join
50 and older, any sex, with Neovascular Age-related Macular Degeneration. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT02843490
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Ranibizumab
Trials testing the same drug.
- NCT06847542 — A Study of 36-Week Refill Exchanges of Port Delivery System (PDS) With Ranibizumab in nAMD · Phase 3 · recruiting
- NCT06957080 — A Study of 2 Doses of EYE103 Compared With Ranibizumab (0.5 mg) in Participants With DME · Phase 2, PHASE3 · active not recruiting
- NCT06176352 — A Study to Evaluate the Efficacy and Safety of Faricimab in Patients With Choroidal Neovascularization Secondary to Path · Phase 3 · active not recruiting
- NCT05126966 — A Study Of The Effectiveness And Safety Of A 36-Week Refill Regimen For The Port Delivery System With Ranibizumab Vs Afl · Phase 3 · withdrawn
- NCT05480293 — This Study Will Compare the Efficacy and Safety of SCT510A Administered by Intravitreal Injection (IVT) With Ranibizumab · Phase 3 · unknown
Other recruiting trials for Neovascular Age-related Macular Degeneration
Currently open trials in the same condition.
- NCT07275840 — A Study to Evaluate the Efficacy and Safety of IBI302inSubjects With nAMD · Phase 2 · recruiting
- NCT06847542 — A Study of 36-Week Refill Exchanges of Port Delivery System (PDS) With Ranibizumab in nAMD · Phase 3 · recruiting
- NCT07053358 — Safety and Efficacy Evaluation of LX111 Gene Therapy in nAMD Patients · EARLY_PHASE1 · recruiting
- NCT06680817 — A Real-World Study to Gain Clinical Insights Into Faricimab (FaReal Study) · recruiting
- NCT06495918 — Study to Evaluate the Efficacy and Safety of Intravitreal OTX-TKI (Axitinib Implant) in Subjects With Neovascular Age- R · Phase 3 · active not recruiting
Other Johannes Gutenberg University Mainz trials
Trials by the same sponsor.
- NCT06269874 — Study Comparing Two Administration Pathways for Adenosine During Microvascular Function Assessment · NA · not yet recruiting
- NCT07076511 — A Novel Intuitive Airway Trolley for Quick Decision-making in Simulated Unexpected Difficult Airway Situations: Evaluati · NA · completed
- NCT06739993 — Effects of Autonomic Nervous System Modulation by Heart Rate Variability Biofeedback Training With Resonant Frequency Br · NA · recruiting
- NCT06514495 — Differential Effects of in Vivo and Virtual Exposure Therapy in Agoraphobia · NA · recruiting
- NCT07460791 — Alcon Hydrus Stent Implantation - Long Term Follow up After 8 Years · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT02843490 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Johannes Gutenberg University Mainz
- Last refreshed: 2 December 2017
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02843490.
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