Efficacy and Safety of Two Treatment Regimens of 0.5 mg Ranibizumab Intravitreal Injections Guided by Functional and/or Anatomical Criteria, in Patients With Neovascular Age-related Macular Degeneration
CompletedPhase 3Results postedLast updated 14 August 2017
What this trial tests
Phase 3 trial testing Ranibizumab in Neovascular Age-related Macular Degeneration in 671 participants. Completed in 9 July 2015.
50 and older, any sex, with Neovascular Age-related Macular Degeneration. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Average Best-corrected Visual Acuity (BCVA) (Letters) Change up to Month 12Primary· up to Month 12
Visual acuity (VA) was assessed during every study visit using best correction determined from protocol refraction. VA measurements (number of letters correctly identified) were performed with the patient in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like VA testing charts at a testing distance of 4 meters. This outcome measure describes the difference between the Visual Acuity averaged up to Month 12 Level of VA (Letters) of the Study Eye.
Group
Value
95% CI
RBZ 0.5 mg: VA Only (Group I)
0.1
± 6.79
RBZ 0.5 mg: VA and/or OCT (Group II)
1.0
± 7.25
Change From Baseline in Visual Acuity (Letters) of the Study Eye up to Month 12Secondary· up to Month 12
Visual acuity (VA) was assessed using best correction determined from protocol refraction. VA measurements (number of letters correctly identified) were performed with the patient in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like VA testing charts at a testing distance of 4 meters. This outcome measure describes the difference between the Visual Acuity averaged from Baseline to Month 12 Level of VA (Letters) of the Study Eye.
Group
Value
95% CI
RBZ 0.5 mg: VA Only (Group I)
6.7
± 13.48
RBZ 0.5 mg: VA and/or OCT (Group II)
8.3
± 13.53
Adverse events — posted to ClinicalTrials.gov
Reporting threshold: 2%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
This study will evaluate and compare two individualized ranibizumab treatment regimens in patients with neovascular (wet) AMD aiming to achieve and to maintain a maximum visual function benefit, while aiming to avoid unnecessary intravitreal injections.
The results will be used to generate further recommendations on functional and anatomical monitoring of the disease and timing of treatment administration for patients with neovascular AMD. In this context, the study will investigate the utility of optical coherence tomography (OCT) to aid retreatment decisions with ranibizumab.
Publications & conference data
5 peer-reviewed publications reference this trial (live from Europe PMC):
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 Novartis Pharmaceuticals trials
Trials by the same sponsor.
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· not yet recruiting
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NCT07484269 — PULSE Registry: for Patients Receiving Lutetium (177Lu) Vipivotide Tetraxetan
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NCT07416162 — A Study of Iptacopan in Korean Patients With Paroxysmal Nocturnal Hemoglobinuria or C3 Glomerulopathy
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NCT07387926 — Safety and Efficacy of Asciminib in Pediatrics and Young Adults With Relapse/Refractory (r/r) Philadelphia Positive (Ph+
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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 Novartis Pharmaceuticals
Last refreshed: 14 August 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/NCT01780935.