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

Novartis Pharmaceuticals181 enrolled

Overview

To evaluate the efficacy and safety of 0.5 mg Ranibizumab intravitreal injections in adult patients with visual impairment due to macular edema (ME).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

181

Conditions

Macular Edema (ME)

Interventions

Sham controlOTHER

The sham vial did not contain active drug (empty sterile vial). The sham injection was an imitation of an intravitreal injection using an injection syringe without a needle touching the eye.

RanibizumabDRUG

Ranibizumab 0.5mg/0.5mL was administered intravitreally to the participant.

Eligibility

Sex: ALLMin age: 12 Years

Medical Language ↔ Plain English

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.

Locations (61)

Outcomes

Primary Outcomes

Change From Baseline in Best-corrected Visual Acuity (BCVA) in Study Eye

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.

Time frame: Baseline, Month 2

Secondary Outcomes

Change From Baseline in BCVA in Study Eye up to Month 2

Time frame: Baseline, Month 1, Month 2

Change From Baseline in Central Subfield Thickness (CSFT) in Study Eye

CSFT wasassessed by optical coherence tomography (OCT). A negative change from baseline indicates improvement.

Time frame: Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12

Change From Baseline in Central Subfield Volume (CSFV) in Study Eye

CSFV was assessed OCT. A negative change from baseline indicates improvement.

Time frame: Months 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12

Number of Participants With Presence or Absence of Intra-retinal Fluid in Study Eye Compared to Baseline

The presence of intra-retinal fluid was assessed by OCT.

Time frame: Month 2, Month 6, Month 12

Number of Participants With Presence or Absence of Subretinal Fluid in Study Eye Compared to Baseline

The presence of subretinal fluid was assessed by OCT.

Time frame: Month 2, Month 6, Month 12

Data from ClinicalTrials.gov

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Novartis Investigative Site

Sydney, New South Wales, Australia

Novartis Investigative Site

Westmead, New South Wales, Australia

Novartis Investigative Site

Adelaide, South Australia, Australia

Novartis Investigative Site

Hobart, Tasmania, Australia

Novartis Investigative Site

South Launceston, Tasmania, Australia

Novartis Investigative Site

Leuven, Belgium

Novartis Investigative Site

Halifax, Nova Scotia, Canada

Novartis Investigative Site

Pilsen, Czechia

Novartis Investigative Site

Prague, Czechia

Novartis Investigative Site

Bordeaux, France, France

...and 51 more locations

Number of Participants With Presence of Active Macular Edema (ME) Leakage

The presence of active ME leakage was assessed by fluorescein angiography (FA).

Time frame: Month 2

Number of Participants Requiring Rescue Treatment at 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.

Time frame: Month 1

Average Change From Baseline in BCVA

Time frame: Baseline (BL), month 1 through month 6, month 1 through month 12

Number of Participants With ≥ 1, ≥ 5, ≥ 10 and ≥ 15 Letters Gain or Reaching 84 Letters

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.

Time frame: Month 2, Month 6 , Month 12

Number of Participants With > 1, > 5, > 10 and > 15 Letters Loss

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.

Time frame: Month 2, Month 6, Month 12

Number of Participants With Ranibizumab Treatments

The number of participants administered study treatments, according to treatment frequency, was assessed.

Time frame: Month 12

Number of Participants With Re-treatments

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.

Time frame: Month 6, month 12

Number of Primary Reasons for Decision to Treat by Investigator

The total number of primary reasons for decisions to treat was assessed. A single participant could have had multiple primary reasons for treatment.

Time frame: 12 months