Efficacy and Safety of Ranibizumab in Patients With Visual Impairment Due to Choroidal Neovascularization Secondary to Pathologic Myopia - Full Text View

Purpose

This study is designed to evaluate the efficacy and safety of two different dosing regimens of 0.5 mg ranibizumab given as intravitreal injection in comparison to verteporfin PDT in patients with visual impairment due to choroidal neovascularization (CNV) secondary to pathologic myopia (PM).

Condition	Intervention	Phase
Pathological Myopia	Drug: 0.5 mg ranibizumab driven by disease activity Drug: 0.5 mg ranibizumab driven by stabilization criteria Drug: verteporfin PDT	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	A 12 Month, Phase III, Randomized, Double-masked, Multicenter, Active-controlled Study to Evaluate the Efficacy and Safety of Two Different Dosing Regimens of 0.5 mg Ranibizumab vs. Verteporfin PDT in Patients With Visual Impairment Due to Choroidal Neovascularization Secondary to Pathologic Myopia

Resource links provided by NLM:

Drug Information available for: Verteporfin Ranibizumab

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:

Average level of BCVA (letters) over all monthly post-baseline assessments from Month 1 to Month 3 and the baseline level of BCVA. [ Time Frame: 6 and 12 Months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Difference between the average level of BCVA (letters) over all monthly post-baseline assessments from Month 1 to Month 6 and the baseline level of BCVA. [ Time Frame: 6 and 12 months ] [ Designated as safety issue: No ]
Average level of BCVA (letters) over all monthly post-baseline assessments from Month 1 to Month 12 and the baseline level of BCVA and based on the time course of BCVA changes from baseline [ Time Frame: 6 and 12 months ] [ Designated as safety issue: No ]
Compare the proportion of patients with ≥10 and ≥15 letters gain or reaching 84 letters, and ≥10 and ≥15 letters loss for each month between treatment groups [ Time Frame: 6 and 12 months ] [ Designated as safety issue: No ]
Compare the proportion of patients with presence of active leakage over time up to Month 12 in the treatment groups [ Time Frame: 6 and 12 months ] [ Designated as safety issue: No ]
Number, severity, and relationship to the study drug of the Adverse events as measure of safety and tolerability of 0.5 mg ranibizumab (two regimens) vs. vPDT at Month 3, Month 6 and Month 12. [ Time Frame: 6 and 12 months ] [ Designated as safety issue: Yes ]

Enrollment:	331
Study Start Date:	October 2010
Study Completion Date:	August 2012
Primary Completion Date:	August 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 0.5mg ranibizumab driven by disease activity	Drug: 0.5 mg ranibizumab driven by disease activity
Experimental: 0.5mg ranibizumab driven by stabilization criteria	Drug: 0.5 mg ranibizumab driven by stabilization criteria
Active Comparator: verteporfin PDT	Drug: verteporfin PDT

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Visual impairment due to CNV secondary to PM
Best corrected visual acuity in the study eye > 24 and < 78 ETDRS letters
High myopia (> -6D), anterio-posterior elongation > 26 mm; posterior changes compatible with the pathologic myopia
Either lesion types in the study eye: subfoveal, juxtafoveal, extrafoveal

Exclusion Criteria:

Patients with uncontrolled systemic or ocular diseases
Blood pressure > 150/90 mmHg
History of pan-retinal, focal/grid laser photocoagulation or intraocular treatment with any anti-VEGF or vPDT in the study eye
Intravitreal treatment with corticosteroids or intraocular surgery within last 3 months in the study eye

Other protocol-defined inclusion/exclusion criteria may apply

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01217944

Show 74 Study Locations

Sponsors and Collaborators

Novartis Pharmaceuticals

Genentech

Investigators

Study Director:

Novartis Pharmaceuticals

More Information

No publications provided

Responsible Party:	Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:	NCT01217944 History of Changes
Other Study ID Numbers:	CRFB002F2301, 2010-021662-30
Study First Received:	October 6, 2010
Last Updated:	February 18, 2013
Health Authority:	United States: Food and Drug Administration Austria: AGES-PharmMed LCM Canada: Health Canada France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) Germany: Federal Institute for Drugs and Medical Devices Hungary: National Institute of Pharmacy Hong Kong: Department of Health India: Ministry of Health Italy: The Italian Medicines Agency Japan: Pharmaceuticals and Medical Devices Agency Korea: Food and Drug Administration Latvia: State Agency of Medicines Lithuania: State Medicine Control Agency - Ministry of Health Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products Portugal: National Pharmacy and Medicines Institute Singapore: Health Sciences Authority Slovakia: State Institute for Drug Control Spain: AGEMED (Spanish Agency of Medicinal Products and Health Products) Switzerland: Swissmedic Turkey: Ministry of Health United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Novartis:

Pathologic myopia
PM
choroidal neovascularization

CNV
ranibizumab
verteporfin PDT

Additional relevant MeSH terms:

Myopia
Neovascularization, Pathologic
Vision, Low
Vision Disorders
Myopia, Degenerative
Choroidal Neovascularization
Refractive Errors
Eye Diseases
Metaplasia
Pathologic Processes
Sensation Disorders
Neurologic Manifestations

Nervous System Diseases
Signs and Symptoms
Choroid Diseases
Uveal Diseases
Verteporfin
Photosensitizing Agents
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Pharmacologic Actions
Dermatologic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 19, 2013