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Trial record 1 of 81 for:    CRVO - Central Retinal Vein Occlusion
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Ranibizumab Intravitreal Injections Versus Sham Control in Patients With Central Retinal Vein Occlusion (CRVO) (Camellia)

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ClinicalTrials.gov Identifier: NCT01976312
Recruitment Status : Completed
First Posted : November 5, 2013
Results First Posted : April 24, 2017
Last Update Posted : May 30, 2017
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Brief Summary:
Provide efficacy and safety data on intravitreal injections of ranibizumab 0.5 mg in patients with visual impairment due to macular edema secondary to CRVO

Condition or disease Intervention/treatment Phase
Central Retinal Vein Occlusion Other: Sham injection Drug: Ranibizumab 0.5 mg Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 252 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized Double-masked, Phase III Study Assessing Ranibizumab Intravitreal Injections Versus Sham Control in Patients With Visual Impairment Due to Macular Edema (ME) Secondary to Central Retinal Vein Occlusion (CRVO) [Camellia]
Actual Study Start Date : November 12, 2013
Actual Primary Completion Date : March 14, 2016
Actual Study Completion Date : March 14, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Edema
Drug Information available for: Ranibizumab

Arm Intervention/treatment
Experimental: Ranibizumab 0.5 mg
PRN intravitreal injection
Drug: Ranibizumab 0.5 mg
Ranibizumab solution for injection was supplied in vials. Each vial contained ranibizumab concentration of 10mg/mL labeled as 0.5 mg/0.5 mL, corresponding to a 0.5 mg dose level. Ranibizumab was formulated as a sterile solution aseptically filled in a sterile glass vial for single use only
Other Name: Lucentis

Sham Comparator: Sham injection
As of Month 3, ranibizumab 0.5 mg PRN intravitreal injections
Other: Sham injection
Sham injections referred to the imitation of an intravitreal injection using an injection syringe without needle.




Primary Outcome Measures :
  1. Average Change in Visual Acuity (Letters) From Baseline to Month 1 Through Month 3 [ Time Frame: Baseline, 3 Months ]

    Best Corrected Visual Acuity (BCVA) was assessed in a sitting position using ETDRS-like visual acuity testing charts at an initial testing distance of 4 meters.

    Mean Visual Acuity was averaged over all monthly assessments from month 1 to month 3 and compared to Baseline.



Secondary Outcome Measures :
  1. Average Change of Best Corrected Visual Acuity (BCVA) From Baseline to Month 1 Through Month 12 [ Time Frame: Baseline, 12 months ]
    Best Corrected Visual Acuity (BCVA) was assessed in a sitting position using ETDRS-like visual acuity testing charts at an initial testing distance of 4 meters. Mean Visual Acuity was averaged over all monthly assessments from month 1 to month 12 and compared to Baseline

  2. Best Corrected Visual Acuity (BCVA) Change From Baseline Over Time [ Time Frame: Month 1 to 12 months ]
    Visual acuity (VA) was assessed on both eyes during every study visit using best correction determined from protocol refraction. VA measurements (number of letters correctly identified) were performed with the patient in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity testing charts at a testing distance of 4 meters. This outcome measure describes the change in visual acuity at each visit compared to baseline

  3. Change From Baseline in Central-Sub-Field- Thickness (CSFT) Over Time [ Time Frame: Month 1 to month 12 ]
    OCT (optical coherence tomography) was used to assess CSFT (Central Sub-Field Thickness) representing the average retinal thickness of the circular area within 1 mm diameter around the foveal center.

  4. Number of Participants With a Best Corrected Visual Acuity (BCVA) Improvement of ≥5, ≥10, ≥15, and ≥30 Letters Over Time [ Time Frame: Month 1 to month 12 ]
    Best Corrected Visual Acuity (BCVA) was assessed in a sitting position using ETDRS-like visual acuity testing charts at an initial testing distance of 4 meters.

  5. Number of Participants With Best Corrected Visual Acuity (BCVA)Loss of <15 Letters in the Study Eye Over Time [ Time Frame: Month 1 to 12 months ]
    Visual acuity (VA) was assessed at every study visit using best correction determined from protocol refraction. VA measurements (number of letters correctly identified) were performed with the patient in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity testing charts at a testing distance of 4 meters. This outcome measure describes for each post-baseline month whether or not a patient lost less than 15 letters of VA as compared with baseline.

  6. The Change in Patient Reported Outcomes in NEI-VFQ-25 Score (Composite Score and Subscales) at Month 3, 6 and 12 Compared to Baseline [ Time Frame: Month 3,6 and 12 ]
    The VFQ-25 consists of 25 vision related questions across 11 vision related subscales, including general vision, ocular pain, near activities, distance activities, social function, mental health, role difficulties, dependency, driving, color vision and peripheral vision, and a general health rating. Items are converted to a 0-100 scale on each subscale and for the composite score where higher scores represents better functioning.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria for study and fellow eye:

• Patients with visual impairment secondary to central retinal vein occlusion (CRVO) with a BCVA between 24 and 73 letters in one eye and at least 35 letters in the other eye.

Exclusion Criteria:

  • Pregnant or nursing women or women of child bearing potential unless using an effective contraception

    - Stroke or myocard infarction within 3 months prior to study

  • History of malignancy within the past 5 years
  • Uncontrolled hypertension
  • Active infection or inflammation in any eye
  • use of corticosteroids for at least 30 days in the last 6 months
  • treatment with anti-angiogenic drugs in any eye within last 3 months
  • Panretinal or focal/drid laser photocoagulation within the last 3 and 4 months respectively

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): NCT01976312


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Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
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Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals

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Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01976312     History of Changes
Other Study ID Numbers: CRFB002E2302
First Posted: November 5, 2013    Key Record Dates
Results First Posted: April 24, 2017
Last Update Posted: May 30, 2017
Last Verified: April 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Novartis ( Novartis Pharmaceuticals ):
CRVO, macular edema, vision impairment, retinal vein occlusion, ranibizumab

Additional relevant MeSH terms:
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Retinal Vein Occlusion
Retinal Diseases
Venous Thrombosis
Eye Diseases
Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Ranibizumab
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents