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Regulatory PMS Study for Lucentis® in Patients With Retinopathy of Prematurity

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05304949
Recruitment Status : Recruiting
First Posted : March 31, 2022
Last Update Posted : September 16, 2022
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Tracking Information
First Submitted Date March 22, 2022
First Posted Date March 31, 2022
Last Update Posted Date September 16, 2022
Actual Study Start Date June 22, 2022
Estimated Primary Completion Date January 12, 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 22, 2022)		 Incidence of adverse events/adverse drug reactions [ Time Frame: Up to 12 weeks ]
Incidence of adverse events/adverse drug reactions, serious adverse events/adverse drug reactions, unexpected adverse events/adverse drug reactions, suspected unexpected serious adverse reactions/adverse drug reactions will be collected
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: March 22, 2022)		 Proportion of treatment success [ Time Frame: Up to 12 weeks ]
Proportion of treatment success, defined as regression of proliferative phase and/or complete peripheral retinal vascularization as assessed by the investigator
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Regulatory PMS Study for Lucentis® in Patients With Retinopathy of Prematurity
Official Title Regulatory Post-Marketing Surveillance(PMS) Study for Lucentis®(Ranibizumab) in Patients With Retinopathy of Prematurity
Brief Summary This study is an open-labeled, multicenter, single arm, observational post-marketing surveillance study under routine clinical practice with no mandated treatments, visits or assessments.
Detailed Description

The investigators will collect safety information and evaluate effectiveness in patients who are prescribed with Lucentis® (Ranibizumab) injection in Retinopathy of Prematurity indication after receiving informed consent over a period of 4 weeks.

Subjects who received multiple doses, i.e., 2 or more doses, of Lucentis® injection will be defined as subjects with long-term use, and the safety and effectiveness information of up to 12 weeks will be collected and analyzed separately.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Korean patients who are prescribed with Lucentis® (Ranibizumab) injection in ROP indication
Condition Retinopathy of Prematurity
Intervention Other: Lucentis
There is no treatment allocation. Patients administered Lucentis by prescription will be enrolled.
Other Name: Ranibizumab
Study Groups/Cohorts Lucentis
Patients prescribed with Lucentis
Intervention: Other: Lucentis
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: March 22, 2022)		 60
Original Estimated Enrollment Same as current
Estimated Study Completion Date January 12, 2025
Estimated Primary Completion Date January 12, 2025   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  1. Premature infants with retinopathy of prematurity (ROP)
  2. Patients (infants) prescribed with Lucentis® injection according to the product approval information in the Republic of Korea
  3. In the case that the legal guardian of the patient (infant) provided a written consent to participate in this study

Exclusion Criteria:

  1. In the case that the legal guardian of the patient (infant) does not want participation in this study

  2. In the case that it falls under any of the contraindications listed in local prescribing information of Lucentis® injection

    • Patients with hypersensitivity to the active substance or to any of the excipients
    • Patients with an active or suspected ocular or periocular infection.
    • Patients with active intraocular inflammation
Sex/Gender
Sexes Eligible for Study: All
Ages up to 10 Years   (Child)
Accepts Healthy Volunteers No
Contacts
Contact: Novartis Pharmaceuticals +41613241111 novartis.email@novartis.com
Contact: Novartis Pharmaceuticals
Listed Location Countries Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number NCT05304949
Other Study ID Numbers CRFB002HKR01
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: No
Current Responsible Party Novartis ( Novartis Pharmaceuticals )
Original Responsible Party Same as current
Current Study Sponsor Novartis Pharmaceuticals
Original Study Sponsor Same as current
Collaborators Not Provided
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
PRS Account Novartis
Verification Date September 2022