Efficacy Study of Lucentis in the Treatment of Retinoblastoma

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-07-31

Study Completion Date

2015-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This study will evaluate the clinical efficacy of intravitreal injections of Ranibizumab (Lucentis) together with chemotherapy in the treatment of Retinoblastoma as compared to chemotherapy alone.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A 24-week Study Evaluating the Effectiveness and Safety of Lucentis® 0.2mg in Retinopathy of Prematurity Participants in China

NCT05576792

Retinopathy of Prematurity

COMPLETED

Study To Determine Safety/Efficacy of Lucentis For Treatment Of Retinal Angiomatous Proliferation Secondary To Age Related Macular Degeneration

NCT00395707

Macular Degeneration

COMPLETED PHASE1/PHASE2

Intravitreal Ranibizumab (Lucentis®) in the Treatment of Non-leaking Macular Cysts in Retinal Dystrophy

NCT03763227

Retinal Dystrophies

COMPLETED PHASE2

Investigates Improvement in Vision Following Switching From Avastin and Macugen Over to Lucentis

NCT00804934

Wet AMD

COMPLETED

Intravitreal Ranibizumab for the Prevention of Radiation Maculopathy Following Plaque Radiotherapy

NCT00540930

Uveal Melanoma Radiation Retinopathy Radiation Maculopathy

UNKNOWN PHASE4

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

This study will be a phase II open label interventional case series. Patients with retinoblastoma will be randomized to receive chemotherapy with or without intravitreal ranibizumab at a dose of 0.5mg/0.05 ml. Patients will receive ranibizumab via a pars plana injection on a monthly basis for a total duration of therapy of 6 months. Patients will be followed for 24 months .

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Retinoblastoma

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Lucentis; chemotherapy

Lucentis: 0.5mg/0.05 ml;Other Name: Ranibizumab;monthly for the first six months.

Chemotherapy:vincristine,1.5mg/m2;carboplatin,560mg/ m2;etoposide,150 mg/ m2.monthly for the first six months.

Group Type EXPERIMENTAL

Lucentis, chemotherapy

Intervention Type DRUG

Lucentis:0.50mg/0.05ml, intravitreal injection,monthly for the first six months.

chemotherapy:vincristine,1.5mg/m2;carboplatin,560mg/ m2;etoposide,150 mg/ m2.

chemotherapy

chemotherapy:vincristine,1.5mg/m2;carboplatin,560mg/ m2;etoposide,150 mg/ m2.monthly for the first six months.

Group Type ACTIVE_COMPARATOR

chemotherapy

Intervention Type DRUG

chemotherapy:vincristine,1.5mg/m2;carboplatin,560mg/ m2;etoposide,150 mg/ m2.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Lucentis, chemotherapy

Lucentis:0.50mg/0.05ml, intravitreal injection,monthly for the first six months.

chemotherapy:vincristine,1.5mg/m2;carboplatin,560mg/ m2;etoposide,150 mg/ m2.

Intervention Type DRUG

chemotherapy

chemotherapy:vincristine,1.5mg/m2;carboplatin,560mg/ m2;etoposide,150 mg/ m2.

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Ranibizumab vincristine; carboplatin; etoposide.

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Ability to provide written informed consent and comply with study assessments for the full duration of the study.
* Definite characteristic signs of retinoblastoma,Group D base on Intraocular International Retinoblastoma classify, IIRC.

Exclusion Criteria

* History of surgical intervention for retinoblastoma in the study eye.
* Any previous disease in the study eye.
* Previous participation in any studies of investigational drugs within 1 month preceding Day 0 (excluding vitamins and minerals).
* Previous participation in a clinical trial (for either eye) involving anti angiogenic drugs (pegaptanib, ranibizumab, anecortave acetate, protein kinase C inhibitors, etc.)

Eligible Sex

ALL

Accepts Healthy Volunteers

No