Phase 3
N=671
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
Neovascular Age-related Macular Degeneration
Bottom Line
View on ClinicalTrials.gov: NCT01780935 ↗Enrolled (actual)
671
Serious AEs
11.2%
Results posted
Jan 2017
Primary outcome: Primary: Average Best-corrected Visual Acuity (BCVA) (Letters) Change up to Month 12 — 0.1; 1.0 Letters correctly read
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Ranibizumab (Drug)
- Age
- Adult, Older Adult · 50+ yrs
- Sex
- All
- Sponsor
- Novartis Pharmaceuticals
- Primary completion
- Jul 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Average Best-corrected Visual Acuity (BCVA) (Letters) Change up to Month 12 |
0.1; 1.0 | — |
| SECONDARY Change From Baseline in Visual Acuity (Letters) of the Study Eye up to Month 12 |
6.7; 8.3 | — |
| SECONDARY Gain of Equal or More Than 1, 5, 10, or 15 Letters in Visual Acuity of the Study Eye From Baseline, at Month 12 and 24 |
— | — |
| SECONDARY Loss of Less Than 5, 10, and 15 Letters in Visual Acuity in the Study Eye From Baseline, at Month 12 and 24 |
— | — |
| SECONDARY Visual Acuity of 73 Letters or More in the Study Eye at Month 12 and 24 |
— | — |
| SECONDARY Average Visual Acuity Change From Month 3 to Month 4 Through Month 24 in the Study Eye |
— | — |
| SECONDARY Average Visual Acuity Change From Baseline to Month 1 Through Month 12 and 24 in the Study Eye |
— | — |
| SECONDARY Change From Baseline in Central Sub-Field Thickness (CSFT) and Central Sub-Field Volume (CSFV) of the Study Eye Over Time |
— | — |
| SECONDARY Dry Retina in the Study Eye on OCT at Month 12 and 24 |
— | — |
| SECONDARY Change From Baseline in Lesion Size and Morphology Based on Fluorescein Angiography at Month 12 and 24 |
— | — |
| SECONDARY Treatment Patterns Over Time in Both Treatment Arms |
— | — |
| SECONDARY Change From Baseline in the National Eye Institute Visual Functioning Questionnaire (NEI-VFQ-25) Scores Over Time |
— | — |
| SECONDARY Frequency and Severity of Ocular and Non-ocular Adverse Events Over Time |
— | — |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- Visual impairment predominantly due to neovascular age-related macular degeneration AMD
- Active, newly diagnosed, untreated CNV due to AMD
- CNV involving the center of the retina
- A qualifying vision score at study entry
Exclusion Criteria
- Stroke or myocardial infarction less than 3 Months prior to study entry
- Active injection or inflammation of either eye at the time of study entry
Data sourced from ClinicalTrials.gov (NCT01780935). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.