Phase 3
N=178
To Assess the Efficacy and Safety of Intravitreal Ranibizumab in People With Vision Loss Due to Macular Edema
Macular Edema (ME)
Bottom Line
View on ClinicalTrials.gov: NCT01846299 ↗Enrolled (actual)
178
Serious AEs
12.4%
Results posted
May 2016
Primary outcome: Primary: Change From Baseline in Best-corrected Visual Acuity (BCVA) in Study Eye — 5.7; 2.9 letters — p=0.0111
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Sham control (Other); Ranibizumab (Drug)
- Age
- Pediatric, Adult, Older Adult · 12+ yrs
- Sex
- All
- Sponsor
- Novartis Pharmaceuticals
- Primary completion
- Sep 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Best-corrected Visual Acuity (BCVA) in Study Eye |
5.7; 2.9 | 0.0111 sig |
| SECONDARY Change From Baseline in BCVA in Study Eye up to Month 2 |
4.7; 1.4; 5.8; 2.8 | — |
| SECONDARY Change From Baseline in Central Subfield Thickness (CSFT) in Study Eye |
-83.6; -14.3; -82.5; -30.6; -86.5; -92.2 | — |
| SECONDARY Change From Baseline in Central Subfield Volume (CSFV) in Study Eye |
-0.296; -0.032; -0.276; -0.104; -0.322; -0.348 | — |
| SECONDARY Number of Participants With Presence or Absence of Intra-retinal Fluid in Study Eye Compared to Baseline |
98; 46; 14; 13; 97; 43 | — |
| SECONDARY Number of Participants With Presence or Absence of Subretinal Fluid in Study Eye Compared to Baseline |
77; 33; 36; 26; 75; 35 | — |
| SECONDARY Number of Participants With Presence of Active Macular Edema (ME) Leakage |
96; 53 | — |
| SECONDARY Number of Participants Requiring Rescue Treatment at Month 1 |
0; 0 | — |
| SECONDARY Average Change From Baseline in BCVA |
6.39; 4.50; 7.40; 5.82 | — |
| SECONDARY Number of Participants With ≥ 1, ≥ 5, ≥ 10 and ≥ 15 Letters Gain or Reaching 84 Letters |
26; 7; 35; 11; 55; 19 | — |
| SECONDARY Number of Participants With > 1, > 5, > 10 and > 15 Letters Loss |
17; 9; 8; 4; 2; 3 | — |
| SECONDARY Number of Participants With Ranibizumab Treatments |
0; 0; 2; 13; 6; 0 | — |
| SECONDARY Number of Participants With Re-treatments |
34; 15; 0; 15; 3; 0 | — |
| SECONDARY Number of Primary Reasons for Decision to Treat by Investigator |
38; 22; 0; 637; 345; 1 | — |
Summary
To evaluate the efficacy and safety of 0.5 mg Ranibizumab intravitreal injections in adult patients with visual impairment due to macular edema (ME).
Eligibility Criteria
Inclusion Criteria
- Diagnosis of active ME secondary to any causes (for adult patients: except diabetic macular edema (DME), age-related macular degeneration (AMD) and retinal vein occlusion (RVO));
- BCVA must be between ≥ 24 and ≤ 83 letters;
- Visual loss should be mainly due to the presence of any eligible types of ME.
Exclusion Criteria
- Women of child-bearing potential,
- Active malignancies;
- History of stroke less than 6 months prior to screening;
- Uncontrolled systemic inflammation or infection, related directly to the underlying causal disease of ME;
- Active diabetic retinopathy, active ocular/periocular infectious disease or active severe intra-ocular inflammation;
- Any type of advanced, severe or unstable ocular disease or its reatment;
- ME with a high likelihood of spontaneous resolution.
Other protocol-defined inclusion/exclusion criteria may apply.
Data sourced from ClinicalTrials.gov (NCT01846299). 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.