NCT01976312 (Camellia) is a Phase 3 clinical trial of Sham injection in Central Retinal Vein Occlusion, sponsored by Novartis Pharmaceuticals.

Who is sponsoring NCT01976312?

NCT01976312 is sponsored by Novartis Pharmaceuticals.

What drugs are being tested in NCT01976312?

Interventions in NCT01976312: Sham injection, Ranibizumab 0.5 mg.

What condition does NCT01976312 study?

NCT01976312 studies Central Retinal Vein Occlusion.

Is NCT01976312 still recruiting?

NCT01976312 is currently completed. Last updated 30 May 2017.

Are results published for NCT01976312?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2017-05-30 · How we verify

NCT01976312: Camellia

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Completed Phase 3 Results posted Last updated 30 May 2017

What this trial tests

Phase 3 trial testing Sham injection in Central Retinal Vein Occlusion in 252 participants. Completed in 14 March 2016.

Timeline

12 November 2013

Primary endpoint
14 March 2016

14 March 2016

Quick facts

Lead sponsor	Novartis Pharmaceuticals
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	252
Start date	12 November 2013
Primary completion	14 March 2016
Estimated completion	14 March 2016
Sites	34 locations across Hong Kong, Taiwan, Indonesia, Vietnam, Philippines, China, India

Drugs / interventions tested

Sham injection — full drug profile →
Ranibizumab 0.5 mg — full drug profile →

Conditions studied

Central Retinal Vein Occlusion — all drugs for Central Retinal Vein Occlusion →

Sponsor

Novartis Pharmaceuticals — full company profile →

Who can join

18 and older, any sex, with Central Retinal Vein Occlusion. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Average Change in Visual Acuity (Letters) From Baseline to Month 1 Through Month 3 Primary · 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.

Group	Value	95% CI
Ranibizumab 0.5 mg	11.3	± 10.77
Sham Injection	-2.7	± 13.92

Average Change of Best Corrected Visual Acuity (BCVA) From Baseline to Month 1 Through Month 12 Secondary · Baseline, 12 months

Group	Value	95% CI
Ranibizumab 0.5 mg	12.4	± 11.43
Sham Injection	3.2	± 14.62

Best Corrected Visual Acuity (BCVA) Change From Baseline Over Time Secondary · 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

Month 1

Group	Value	95% CI
Ranibizumab 0.5 mg	9.6	± 10.2
Sham Injection	-0.9	± 12.17

Month 2

Group	Value	95% CI
Ranibizumab 0.5 mg	11.6	± 12.39
Sham Injection	-3.4	± 16.04

Month 3

Group	Value	95% CI
Ranibizumab 0.5 mg	12.6	± 12.01
Sham Injection	-3.8	± 17.02

Month 4

Group	Value	95% CI
Ranibizumab 0.5 mg	10.7	± 12.56
Sham Injection	2.8	± 15.26

Month 5

Group	Value	95% CI
Ranibizumab 0.5 mg	11.7	± 12.62
Sham Injection	3.9	± 15.26

Month 6

Group	Value	95% CI
Ranibizumab 0.5 mg	12.3	± 13.10
Sham Injection	3.8	± 17.20

Month 7

Group	Value	95% CI
Ranibizumab 0.5 mg	12.9	± 13.36
Sham Injection	5.0	± 16.71

Month 8

Group	Value	95% CI
Ranibizumab 0.5 mg	12.4	± 14.01
Sham Injection	6.0	± 16.01

Change From Baseline in Central-Sub-Field- Thickness (CSFT) Over Time Secondary · 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.

Month 1

Group	Value	95% CI
Ranibizumab 0.5 mg	-393.7	± 275.13
Sham Injection	-13.3	± 207.55

Month 2

Group	Value	95% CI
Ranibizumab 0.5 mg	-412.6	± 297.50
Sham Injection	-7.9	± 196.65

Month 3

Group	Value	95% CI
Ranibizumab 0.5 mg	-433.3	± 290.84
Sham Injection	-84.4	± 274.98

Month 4

Group	Value	95% CI
Ranibizumab 0.5 mg	-367.8	± 305.26
Sham Injection	-364.8	± 250.48

Month 5

Group	Value	95% CI
Ranibizumab 0.5 mg	-407.0	± 309.58
Sham Injection	-369.6	± 273.92

Month 6

Group	Value	95% CI
Ranibizumab 0.5 mg	-426.6	± 294.63
Sham Injection	-372.3	± 301.24

Month 7

Group	Value	95% CI
Ranibizumab 0.5 mg	-421.5	± 316.14
Sham Injection	-392.7	± 288.74

Month 8

Group	Value	95% CI
Ranibizumab 0.5 mg	-398.9	± 299.67
Sham Injection	-405.2	± 289.49

Number of Participants With a Best Corrected Visual Acuity (BCVA) Improvement of ≥5, ≥10, ≥15, and ≥30 Letters Over Time Secondary · 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.

Month 1 Gain of >=5 letters

Group	Value	95% CI
Ranibizumab 0.5 mg	141
Sham Injection	17

Month 1 Gain of >=10 letters

Group	Value	95% CI
Ranibizumab 0.5 mg	94
Sham Injection	6

Month 1 Gain of >=15 letters

Group	Value	95% CI
Ranibizumab 0.5 mg	56
Sham Injection	2

Month 1 Gain of >=30 letters

Group	Value	95% CI
Ranibizumab 0.5 mg	3
Sham Injection	0

Month 2 Gain of >=5 letters

Group	Value	95% CI
Ranibizumab 0.5 mg	150
Sham Injection	18

Month 2 Gain of >=10 letters

Group	Value	95% CI
Ranibizumab 0.5 mg	119
Sham Injection	11

Month 2 Gain of >=15 letters

Group	Value	95% CI
Ranibizumab 0.5 mg	74
Sham Injection	3

Month 2 Gain of >=30 letters

Group	Value	95% CI
Ranibizumab 0.5 mg	9
Sham Injection	0

Number of Participants With Best Corrected Visual Acuity (BCVA)Loss of <15 Letters in the Study Eye Over Time Secondary · 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.

Month 1, Loss of < 15 letters

Group	Value	95% CI
Ranibizumab 0.5 mg	185
Sham Injection	57

Month 2, Loss of < 15 letters

Group	Value	95% CI
Ranibizumab 0.5 mg	182
Sham Injection	53

Month 3, Loss of < 15 letters

Group	Value	95% CI
Ranibizumab 0.5 mg	182
Sham Injection	51

Month 4, Loss of < 15 letters

Group	Value	95% CI
Ranibizumab 0.5 mg	179
Sham Injection	55

Month 5, Loss of < 15 letters

Group	Value	95% CI
Ranibizumab 0.5 mg	182
Sham Injection	56

Month 6, Loss of < 15 letters

Group	Value	95% CI
Ranibizumab 0.5 mg	180
Sham Injection	53

Month 7, Loss of < 15 letters

Group	Value	95% CI
Ranibizumab 0.5 mg	181
Sham Injection	55

Month 8, Loss of < 15 letters

Group	Value	95% CI
Ranibizumab 0.5 mg	177
Sham Injection	55

The Change in Patient Reported Outcomes in NEI-VFQ-25 Score (Composite Score and Subscales) at Month 3, 6 and 12 Compared to Baseline Secondary · 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.

Month 3

Group	Value	95% CI
Ranibizumab 0.5 mg	4.4	± 12.54
Sham Injection	0.1	± 13.78

Month 6

Group	Value	95% CI
Ranibizumab 0.5 mg	6.7	± 15.02
Sham Injection	2.9	± 13.33

Month 12

Group	Value	95% CI
Ranibizumab 0.5 mg	8.2	± 13.70
Sham Injection	3.2	± 15.34

Adverse events — posted to ClinicalTrials.gov

Reporting threshold: 1%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Ranibizumab 0.5 mg

Serious: 11/190 (6%)

Deaths: —

Sham With Ranibizumab 0.5 mg

Serious: 5/56 (9%)

Deaths: —

Sham Without Ranibizumab 0.5 mg

Serious: 1/5 (20%)

Deaths: —

Serious adverse events (17 terms)

Reaction	System	Ranibizumab 0.5 mg	Sham With Ranibizumab 0.5 mg	Sham Without Ranibizumab 0…
Angle closure glaucoma	Eye disorders	—	—	—
Acute myocardial infarction	Cardiac disorders	—	—	—
Left ventricular dysfunction	Cardiac disorders	—	—	—
Keratitis	Eye disorders	—	—	—
Macular fibrosis	Eye disorders	—	—	—
Gastric ulcer	Gastrointestinal disorders	—	—	—
Endophthalmitis	Infections and infestations	—	—	—
Herpes zoster	Infections and infestations	—	—	—
Urinary tract infection	Infections and infestations	—	—	—
Wrist fracture	Injury, poisoning and procedural complications	—	—	—
Diabetes mellitus	Metabolism and nutrition disorders	—	—	—
Inflammatory pseudotumour	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—	—
Schwannoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—	—
Haemorrhage intracranial	Nervous system disorders	—	—	—
Transient ischaemic attack	Nervous system disorders	—	—	—
Mediastinal cyst	Respiratory, thoracic and mediastinal disorders	—	—	—
Pulmonary arterial hypertension	Respiratory, thoracic and mediastinal disorders	—	—	—

Other adverse events (67 terms — click to expand)

Reaction	System	Ranibizumab 0.5 mg	Sham With Ranibizumab 0.5 mg	Sham Without Ranibizumab 0…
Nasopharyngitis	Infections and infestations	—	—	—
Conjunctival haemorrhage	Eye disorders	—	—	—
Upper respiratory tract infection	Infections and infestations	—	—	—
Hypertension	Vascular disorders	—	—	—
Intraocular pressure increased	Investigations	—	—	—
Ocular hyperaemia	Eye disorders	—	—	—
Vision blurred	Eye disorders	—	—	—
Visual acuity reduced	Eye disorders	—	—	—
Conjunctivitis	Infections and infestations	—	—	—
Dry eye	Eye disorders	—	—	—
Cough	Respiratory, thoracic and mediastinal disorders	—	—	—
Retinal haemorrhage	Eye disorders	—	—	—
Pharyngitis	Infections and infestations	—	—	—
Eye irritation	Eye disorders	—	—	—
Eye pain	Eye disorders	—	—	—
Eye swelling	Eye disorders	—	—	—
Ocular hypertension	Eye disorders	—	—	—
Diarrhoea	Gastrointestinal disorders	—	—	—
Urinary tract infection	Infections and infestations	—	—	—
Conjunctival hyperaemia	Eye disorders	—	—	—
Macular oedema	Eye disorders	—	—	—
Vitreous floaters	Eye disorders	—	—	—
Gastritis	Gastrointestinal disorders	—	—	—
Diabetes mellitus	Metabolism and nutrition disorders	—	—	—
Asthenopia	Eye disorders	—	—	—
Conjunctival oedema	Eye disorders	—	—	—
Eye pruritus	Eye disorders	—	—	—
Glaucoma	Eye disorders	—	—	—
Iris neovascularisation	Eye disorders	—	—	—
Lacrimation increased	Eye disorders	—	—	—
Macular fibrosis	Eye disorders	—	—	—
Retinal ischaemia	Eye disorders	—	—	—
Retinal vein occlusion	Eye disorders	—	—	—
Vitreal cells	Eye disorders	—	—	—
Constipation	Gastrointestinal disorders	—	—	—
Malaise	General disorders	—	—	—
Arthritis	Musculoskeletal and connective tissue disorders	—	—	—
Back pain	Musculoskeletal and connective tissue disorders	—	—	—
Headache	Nervous system disorders	—	—	—
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	—	—	—

Most-reported serious reactions: Angle closure glaucoma, Acute myocardial infarction, Left ventricular dysfunction, Keratitis, Macular fibrosis, Gastric ulcer, Endophthalmitis, Herpes zoster.

Data from ClinicalTrials.gov NCT01976312 adverse events section.

Sponsor's own description

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

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other trials of Sham injection

Trials testing the same drug.

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Other recruiting trials for Central Retinal Vein Occlusion

Currently open trials in the same condition.

NCT05476926 — A Real-World Study to Gain Clinical Insights Into Roche Ophthalmology Products · active not recruiting

Other Novartis Pharmaceuticals trials

Trials by the same sponsor.

NCT07498335 — Study to Assess the Efficacy, Pharmacokinetics, Safety and Tolerability of Atrasentan in Pediatric Patients With Primary · Phase 3 · not yet recruiting
NCT07489573 — Study of Efficacy and Safety of Secukinumab in Chinese Adult Patients With Moderate to Severe Hidradenitis Suppurativa · Phase 4 · not yet recruiting
NCT07484269 — PULSE Registry: for Patients Receiving Lutetium (177Lu) Vipivotide Tetraxetan · not yet recruiting
NCT07416162 — A Study of Iptacopan in Korean Patients With Paroxysmal Nocturnal Hemoglobinuria or C3 Glomerulopathy · not yet recruiting
NCT07387926 — Safety and Efficacy of Asciminib in Pediatrics and Young Adults With Relapse/Refractory (r/r) Philadelphia Positive (Ph+ · Phase 1, PHASE2 · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT01976312 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Novartis Pharmaceuticals
Last refreshed: 30 May 2017

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01976312.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing

NCT01976312: Camellia

Quick facts

Drugs / interventions tested

Conditions studied

Sponsor

Who can join

Results — posted to ClinicalTrials.gov

Adverse events — posted to ClinicalTrials.gov

Serious adverse events (17 terms)

Sponsor's own description

Publications & conference data

Related trials

Other trials of Sham injection

Other recruiting trials for Central Retinal Vein Occlusion

Other Novartis Pharmaceuticals trials

Verify against primary sources