Assess the Efficacy/Safety of Intravitreal Ranibizumab in Patients With Vision Loss Due to Choroidal Neovascularization.
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| ClinicalTrials.gov Identifier: NCT01840410 |
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Recruitment Status :
Completed
First Posted : April 25, 2013
Results First Posted : August 26, 2016
Last Update Posted : August 26, 2016
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Sponsor:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
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Brief Summary:
This study was conducted to evaluate the efficacy and safety of 0.5 mg ranibizumab in adult and adolescent patients with visual impairment due to choridal neovascularization (CNV).
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Choroidal Neovascularization (CNV) | Drug: Ranibizumab Other: Sham control | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 183 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Triple (Participant, Investigator, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official Title: | A 12-month, Randomized, Double-masked, Sham-controlled, Multicenter Study to Evaluate the Efficacy and Safety of 0.5mg Ranibizumab Intravitreal Injections in Patients With Visual Impairment Due to Vascular Endothelial Growth Factor (VEGF) Driven Choroidal Neovascularization. |
| Study Start Date : | September 2013 |
| Actual Primary Completion Date : | November 2015 |
| Actual Study Completion Date : | November 2015 |
Resource links provided by the National Library of Medicine
Drug Information available for:
Ranibizumab
| Arm | Intervention/treatment |
|---|---|
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Experimental: 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.
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Drug: Ranibizumab
Ranibizumab 0.5mg/0.5mL was administered intravitreally to the participant. |
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Sham Comparator: 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 could switch to open-label ranibizumab on an as needed basis.
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Other: Sham control
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. |
Primary Outcome Measures :
- Change From Baseline in Best-corrected Visual Acuity (BCVA) in Study Eye to Month 2 [ Time Frame: 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. The data were analyzed using mixed model repeated measures (MMRM) which contained scheduled visit, the type of underlying pathophysiologic mechanism (angloid streaks versus others) and treatment group as fixed effect factors, centered baseline BCVA as a continuous covariate and treatment group by visit and visit by centered baseline BCVA interactions. A positive change from baseline indicated improvement.
Secondary Outcome Measures :
- Change From Baseline in BCVA in Study Eye up to Month 2 [ Time Frame: 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. The data were analyzed using analysis of covariance (ANCOVA) model which contained the type of underlying pathophysiologic mechanism (angloid streaks versus others) and treatment group as fixed effect factors, centered baseline BCVA as a continuous covariate. A positive change from baseline indicated improvement.
- Change From Baseline in Central Subfield Thickness (CSFT) in Study Eye [ Time Frame: Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 ]CSFT was assessed by optical coherence tomography (OCT). A negative change from baseline indicates improvement.
- Change From Baseline in Central Subfield Volume (CSFV) in Study Eye [ Time Frame: Baseline, 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 Presence of Intra-retinal Fluid in Study Eye Compared to Baseline [ Time Frame: Baseline, Month 2, Month 6, Month 12 ]The presence of intra-retinal fluid was assessed by OCT.
- Number of Participants With Presence of Subretinal Fluid in Study Eye Compared to Baseline [ Time Frame: Baseline, Month 2, Month 6, Month 12 ]Presence of subretinal fluid in study eye compared to baseline
- Number of Participants With Presence of Active Chorioretinal Leakage [ Time Frame: Baseline, Month 2, Month 6, Month 12 ]The presence of active chorioretinal leakage was assessed by photography imaging, i.e. fluorescein angiography (FA).
- Average Change From Baseline in BCVA [ Time Frame: 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. BCVA was assessed at each month from Month 1 through Month 6 or at each month from Month 1 through month 12, and the data were averaged. The outcome measure is reporting the change between baseline and average BCVA from Month 1 through Month 6 or from Month 1 through Month 12 (average BCVA - baseline BCVA). A positive change from baseline indicated improvement.
- Number of Participants With ≥ 1, ≥ 5, ≥ 10 and ≥ 15 Letters Gain or Reaching 84 Letters [ Time Frame: 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 > 1, > 5, > 10 and > 15 Letters Loss [ Time Frame: 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 Requirement for Rescue Treatment at Month 1 [ Time Frame: 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.
- Number of Participants With Ranibizumab Treatments in Study Eye [ Time Frame: Month 12 ]The number of participants administered study treatments, according to treatment frequency, was assessed.
- Number of Participants With Re-treatments [ Time Frame: 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 Primary Reasons for Decision to Treat by Investigator [ Time Frame: Month 12 ]The total number of primary reasons for decisions to treat was assessed. A single participant could have had multiple primary reasons for treatment.
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| Ages Eligible for Study: | 12 Years and older (Child, Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Key Inclusion Criteria:
- Diagnosis of active CNV secondary to any causes with the CNV or its sequelae affecting the fovea;
- BCVA must be between ≥ 24 and ≤ 83 letters in the study eye;
- Visual loss in the study eye should mainly be due to the presence of any eligible types of CNV;
Key Exclusion Criteria:
- Women of child-bearing potential;
- Active malignancies;
- History of stroke less than 6 months prior to screening;
- Uncontrolled systemic inflammation or infection;
- Active diabetic retinopathy, active ocular/periocular infectious disease or active severe intra-ocular inflammation;
- CNV- conditions with a high likelihood of spontaneous resolution;
- History of intravitreal treatment with steroids;
- History of laser photocoagulation;
- History of intraocular treatment with any anti-angiogenic drugs.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01840410
Locations
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Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
| Study Director: | Novartis Pharmaceuticals | Novartis Pharmaceuticals |
| Responsible Party: | Novartis Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT01840410 |
| Other Study ID Numbers: |
CRFB002G2301 2012-005417-38 ( EudraCT Number ) |
| First Posted: | April 25, 2013 Key Record Dates |
| Results First Posted: | August 26, 2016 |
| Last Update Posted: | August 26, 2016 |
| Last Verified: | August 2016 |
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
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Vision Impairment Abnormal growth of blood vessels |
Additional relevant MeSH terms:
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Choroidal Neovascularization Neovascularization, Pathologic Metaplasia Pathologic Processes Choroid Diseases Uveal Diseases Eye Diseases |
Ranibizumab Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Physiological Effects of Drugs Growth Inhibitors Antineoplastic Agents |