Ranibizumab Intravitreal Injections Versus Sham Control in Patients With Central Retinal Vein Occlusion (CRVO) (Camellia)

• 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: Novartis Pharmaceuticals
• Information provided by (Responsible Party): Novartis ( Novartis Pharmaceuticals )

Study Description

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

Study Design

• 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

Arms and Interventions

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.

Outcome Measures

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.

Eligibility Criteria

• 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

Contacts and Locations

Locations

China, Beijing

Novartis Investigative Site

Beijing, Beijing, China, 100191

Novartis Investigative Site

Beijing, Beijing, China, 100730

China, Chongqing

Novartis Investigative Site

Chongqing, Chongqing, China, 400042

China, Guangdong

Novartis Investigative Site

Guangzhou, Guangdong, China, 510060

Novartis Investigative Site

Shantou, Guangdong, China, 515041

China, Heilongjiang

Novartis Investigative Site

Harbin, Heilongjiang, China, 150001

China, Hubei

Novartis Investigative Site

Wuhan, Hubei, China, 430070

China, Hunan

Novartis Investigative Site

Changsha, Hunan, China, 410011

China, Jiangsu

Novartis Investigative Site

Nanjing, Jiangsu, China, 210006

Novartis Investigative Site

Nanjing, Jiangsu, China, 210029

Novartis Investigative Site

Nantong, Jiangsu, China, 226000

China, Jiangxi

Novartis Investigative Site

Nanchang, Jiangxi, China, 330006

China, Shandong

Novartis Investigative Site

Qingdao, Shandong, China, 266011

China, Sichuan

Novartis Investigative Site

Chengdu, Sichuan, China, 610041

China, Tianjin

Novartis Investigative Site

Tianjin, Tianjin, China, 300020

Novartis Investigative Site

Tianjin, Tianjin, China, 300070

China, Zhejiang

Novartis Investigative Site

Wenzhou, Zhejiang, China, 325027

China

Novartis Investigative Site

Beijing, China, 100034

Novartis Investigative Site

Beijing, China, 100176

Novartis Investigative Site

Beijing, China, 100730

Novartis Investigative Site

Chongqing, China, 400038

Novartis Investigative Site

Shanghai, China, 200080

Novartis Investigative Site

Shanghai, China, 200092

Hong Kong

Novartis Investigative Site

Hongkong, Hong Kong

India

Novartis Investigative Site

Ahmedabad, Gujarat, India, 380 016

Novartis Investigative Site

Bhubaneswar, Orissa, India, 751 024

Indonesia

Novartis Investigative Site

Bandung, Jawa Barat, Indonesia, 40117

Novartis Investigative Site

Jakarta, Indonesia, 10430

Philippines

Novartis Investigative Site

Manila, Metro Manila, Philippines, 1000

Novartis Investigative Site

San Juan City, Philippines, 1500

Taiwan

Novartis Investigative Site

Lin-Kou, Taiwan, 33305

Novartis Investigative Site

Taipei, Taiwan

Vietnam

Novartis Investigative Site

Hanoi, Vietnam, 10000

Novartis Investigative Site

Ho Chi Minh City, Vietnam, 70000

Sponsors and Collaborators

Novartis Pharmaceuticals

Investigators

• Study Director: Novartis Pharmaceuticals; Novartis Pharmaceuticals

More Information

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

• 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:

Retinal Vein Occlusion; Retinal Diseases; Eye Diseases; Venous Thrombosis; Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Ranibizumab; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Physiological Effects of Drugs; Growth Inhibitors; Antineoplastic Agents