Last reviewed · How we verify
NCT03651011: NIRVANA
Navigated Laser In Branch Retinal Vein Occlusion Study
NA trial testing Aflibercept Injection [Eylea] in Branch Retinal Vein Occlusion in 47 participants. Completed in 5 October 2021.
5 October 2021
Quick facts
| Lead sponsor | Odense University Hospital |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 47 |
| Start date | 10 August 2018 |
| Primary completion | 5 October 2021 |
| Estimated completion | 5 October 2021 |
| Sites | 2 locations across Denmark |
Drugs / interventions tested
- Aflibercept Injection [Eylea] — full drug profile →
- Navigated laser photocoagulation
Conditions studied
- Branch Retinal Vein Occlusion — all drugs for Branch Retinal Vein Occlusion →
- Macular Edema — all drugs for Macular Edema →
Sponsor
Odense University Hospital
Who can join
18 and older, any sex, with Branch Retinal Vein Occlusion or Macular Edema. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Branch retinal vein occlusion (BRVO) is often complicated by macular edema, possibly leading to severe visual loss or blindness. Treatment is repeated, intravitreal injections of vascular endothelial growth factor (VEGF)-inhibitors like aflibercept. The treatment is effective, but a need for repetitive injections is a concern for patients as well as society due to risk of side effects, regular hospital visits and the price of the drug. Former treatment included macular grid pattern photocoagulation, but this technology was limited by a poorer visual outcome for the patient and a higher risk of side effects, including central visual loss. A novel laser delivery system, called navigated laser photocoagulation, has proven effective, safe and precise, and has shown promising results in stabilising the effect of the VEGF-inhibitor treatment in similar diseases. Thus, in a 12-month prospective, randomized 1:1 study of 60 patients with BRVO and macular edema the investigators aim to (1) Examine the treatment response of patients treated with intravitreal aflibercept (Eylea®) and navigated retinal laser (Navilas®)(Group 1) as compared to patients treated with intravitreal aflibercept only (Group 2), and (2) Identify non-invasive retinal biomarkers (retinal oxygen saturation, macular ischemia and retinal vascular arteriolar and venular calibre) for successful treatment outcome.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
-
Navigated laser and aflibercept versus aflibercept monotherapy in treatment-naïve branch retinal vein occlusion: A 12-month randomized trial.
Frederiksen KH, Vestergaard JP, Pedersen FN, Vergmann AS, et al · · 2022 · cited 4× · PMID 35611568 · DOI 10.1111/aos.15182 -
Predictive value of retinal oximetry, optical coherence tomography angiography and microperimetry in patients with treatment-naïve branch retinal vein occlusion.
Frederiksen KH, Pedersen FN, Vergmann AS, Yang D, et al · · 2023 · cited 2× · PMID 37381014 · DOI 10.1186/s40942-023-00468-7
Verify or expand the search:
- PubMed search for NCT03651011
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Aflibercept Injection [Eylea]
Trials testing the same drug.
- NCT06205979 — Relationship Between Dyslipidemia and The Response of Diabetic Macular Edema to Intravitreal Injection of Anti Vascular · EARLY_PHASE1 · unknown
- NCT06330220 — Visual Function Change in Wet Age-related Macular Degeneration Patients With Better Baseline Visual Acuity · Phase 4 · completed
- NCT03845049 — Comparative Multicenter Randomized Study of Aflibercept Versus Placebo in Macular Telangiectasia Type 1 · Phase 3 · terminated
- NCT03197480 — Diabetic Macular Edema Asian Response (DEAR) Study: Biomarkers for Response to Aflibercept in Asian Patients With Center · Phase 4 · unknown
- NCT03709745 — Eylea and Lucentis for Macular Edema in Branch Retinal Vein Occlusion · Phase 4 · completed
Other recruiting trials for Branch Retinal Vein Occlusion
Currently open trials in the same condition.
- NCT05476926 — A Real-World Study to Gain Clinical Insights Into Roche Ophthalmology Products · active not recruiting
Other Odense University Hospital trials
Trials by the same sponsor.
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- NCT07466212 — QoLIDia: Quality of Life in Cancer Patients With Diabetes During Immunotherapy · not yet recruiting
- NCT07191379 — Self-administered Subcutaneous Daratumumab in Patients With Multiple Myeloma · Phase 4 · not yet recruiting
- NCT07170085 — Positioning of Children With Acute Respiratory Insufficiency · NA · 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 NCT03651011 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Odense University Hospital
- Last refreshed: 20 April 2022
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/NCT03651011.
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