To Assess the Efficacy and Safety of Intravitreal Ranibizumab in People With Vision Loss Due to Macular Edema

Phase 3

Completed

Conditions: Macular Edema (ME)

Interventions: Other: Sham control
Drug: Ranibizumab

Registration Number: NCT01846299

Lead Sponsor: Novartis Pharmaceuticals

Brief 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).

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 181

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sham control	Sham control	Sham injection was given to the study eye at baseline, and then treatment was given based on evidence of disease activity. At month 1, if treatment was needed, sham was administered. At month 2, participants switched to open-label ranibizumab on an as needed basis.
Ranibizumab	Ranibizumab	A 0.5 mg ranibizumab intravitreal injection was given to the study eye at baseline, and then as needed based on evidence of disease activity.

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Best-corrected Visual Acuity (BCVA) in Study Eye	Baseline, Month 2	BCVA was assessed in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity (VA) testing charts at an initial testing distance of 4 meters. A positive change from baseline indicated improvement.

Secondary Outcome Measures

Name	Time	Method
Number of Participants Requiring Rescue Treatment at Month 1	Month 1	Rescue treatment with laser photocoagulation or periocular treatment could be administered at Month 1 only if the participant had a visual acuity loss of \> 5 letters due to disease activity from baseline to Month 1.
Average Change From Baseline in BCVA	Baseline (BL), month 1 through month 6, month 1 through month 12	BCVA was assessed in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity (VA) testing charts at an initial testing distance of 4 meters. A positive change from baseline indicated improvement.
Change From Baseline in BCVA in Study Eye up to Month 2	Baseline, Month 1, Month 2	BCVA was assessed in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity (VA) testing charts at an initial testing distance of 4 meters. A positive change from baseline indicated improvement.
Change From Baseline in Central Subfield Volume (CSFV) in Study Eye	Months 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12	CSFV was assessed OCT. A negative change from baseline indicates improvement.
Number of Participants With Re-treatments	Month 6, month 12	The number of participants, administered re-treatments according to treatment frequency, was assessed. Re-treatment was defined as an administration of study medication following at least one non-missed visit where treatment was not administered in the study eye. Up to Month 12, the maximum number of retreatments was 5.
Number of Participants With Presence or Absence of Intra-retinal Fluid in Study Eye Compared to Baseline	Month 2, Month 6, Month 12	The presence of intra-retinal fluid was assessed by OCT.
Number of Participants With Presence or Absence of Subretinal Fluid in Study Eye Compared to Baseline	Month 2, Month 6, Month 12	The presence of subretinal fluid was assessed by OCT.
Change From Baseline in Central Subfield Thickness (CSFT) in Study Eye	Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12	CSFT wasassessed by optical coherence tomography (OCT). A negative change from baseline indicates improvement.
Number of Participants With Presence of Active Macular Edema (ME) Leakage	Month 2	The presence of active ME leakage was assessed by fluorescein angiography (FA).
Number of Participants With > 1, > 5, > 10 and > 15 Letters Loss	Month 2, Month 6, Month 12	VA measurements (number of letters correctly identified) were performed with the patient in a sitting position using ETDRS-like visual acuity testing charts at a testing distance of 4 meters.
Number of Primary Reasons for Decision to Treat by Investigator	12 months	The total number of primary reasons for decisions to treat was assessed. A single participant could have had multiple primary reasons for treatment.
Number of Participants With ≥ 1, ≥ 5, ≥ 10 and ≥ 15 Letters Gain or Reaching 84 Letters	Month 2, Month 6 , Month 12	VA measurements (number of letters correctly identified) were performed with the patient in a sitting position using ETDRS-like visual acuity testing charts at a testing distance of 4 meters.
Number of Participants With Ranibizumab Treatments	Month 12	The number of participants administered study treatments, according to treatment frequency, was assessed.