Neoplasms

Symptoms and General Pathology

All Conditions

Eye Diseases

Heart and Blood Diseases

Neoplasm Metastasis

Macular Edema

Macular Degeneration

Edema

Retinal Vein Occlusion

Neovascularization, Pathologic

Choroidal Neovascularization

Neoplastic Processes

Retinal Degeneration

Retinal Diseases

Thrombosis

Venous Thrombosis

Embolism

Embolism and Thrombosis

Vascular Diseases

Antineoplastic Agents

All Drugs and Chemicals

Ranibizumab

Angiogenesis Inhibitors

Growth Inhibitors

Ranibizumab 0.5 mg intravitreal injection administered as-needed no more frequently than every 30 days (no more than 12 injections per year) for 24 months.

Ranibizumab intravitreal injection 0.5 mg in a single-dose regimen given on an as needed basis no more frequently than every 30 days (no more than 12 injections per year).

Ranibizumab 0.5 mg

Phillip Lai, M.D.

This is an open-label, multicenter, extension study of intravitreally administered ranibizumab in two cohorts. The first cohort (reported separately under FVF3426g, NCT00379795) enrolled subjects with primary or recurrent Choroidal Neovascularization (CNV) secondary to Age-Related Macular Degeneration (AMD) who completed the treatment phase of a Genentech sponsored study (FVF2598g (NCT00056836), FVF2587g (NCT00061594), or FVF2428g (NCT00056823)). The second cohort (reported here) enrolled subjects with macular edema secondary to Retinal Vein Occlusion (RVO) who completed the 6-month treatment and 6-month observation phases (12 months total) of a Genentech sponsored study (FVF4165g (NCT00486018) or FVF4166g (NCT00485836)). Patients were enrolled within 14 days of completion of the previous study.

An Extension Study to Evaluate Safety and Tolerability of Ranibizumab in Macular Edema Secondary to Retinal Vein Occlusion (Cohort 2)

An Open-Label, Multicenter Extension Study to Evaluate the Safety and Tolerability of Ranibizumab in Subjects With Choroidal Neovascularization (CNV) Secondary to Age-Related Macular Degeneration (AMD) or Macular Edema Secondary to Retinal Vein Occlusion (RVO) Who Have Completed a Genentech-Sponsored Ranibizumab Study

Number of participants with: any ocular adverse events, ocular adverse events causing treatment discontinuation, ocular serious adverse events, intraocular inflammation and cataracts that occurred in the study eye.

Only adverse events that occurred during this extension study are reported. For subjects in the crossover groups who started their first ranibizumab injection in this extension study, adverse events that occurred prior to any ranibizumab injection were also excluded.

Number of participants with non-ocular adverse events (not occurring in the eye) in the following categories: any adverse events, serious adverse events, adverse events leading to study discontinuation and death.

Only adverse events that occurred during this extension study are reported. For subjects in the crossover groups who started their first ranibizumab injection in this extension study, adverse events that occurred prior to any ranibizumab injection were also excluded.

Additional information about adverse events can be found in the adverse events section.

Change from baseline in then BCVA was assessed by the number of letters a patient could read correctly on the Early Treatment Diabetic Retinopathy Study (ETDRS) Eye Chart at a Starting Test Distance of 4 Meters. An increase in the number of letters read indicates improvement in visual acuity.

Change from baseline in Central foveal (retinal) thickness was assessed by Optical Coherence Tomography (OCT). OCT was conducted at the study sites by personnel who were certified by the University of Wisconsin Fundus Photograph Reading Center.

NEI VFQ-25 is a 25 item questionnaire that assesses visual function and quality of life for a total possible score of 0 to 100. A higher score represents better functioning. The change from baseline is calculated at Month 12 and Month 24.

Participants are grouped according to the treatment they received in initial studies FVF4165g BRAVO (NCT00486018) and FVF4166g CRUISE (NCT00485836).

Genentech, Inc.

Safety Population included all participants who received at least one dose of study drug in one of the initial studies or this extension study. These analyses include only those adverse events that occurred during this extension study.

In this extension study participants received Ranibizumab 0.5 mg intravitreal injection administered as-needed no more frequently than every 30 days (no more than 12 injections per year) up to 24 months. Participants in this group received intravitreal sham injections in the 6 month treatment period of BRAVO or the 6 month treatment period of CRUISE and received Ranibizumab during the 6 month observation period of the initial study or this extension study.

Ranibizumab (Sham)

In this extension study participants received Ranibizumab 0.5 mg intravitreal injection administered as-needed no more frequently than every 30 days (no more than 12 injections per year) up to 24 months. Participants in this group received 0.3 mg Ranibizumab intravitreal injections in the 6 month treatment period of BRAVO or the 6 month treatment period of CRUISE.

Ranibizumab (0.3 mg)

In this extension study participants received Ranibizumab 0.5 mg intravitreal injection administered as-needed no more frequently than every 30 days (no more than 12 injections per year) up to 24 months. Participants in this group received 0.5 mg Ranibizumab intravitreal injections in the 6 month treatment period of BRAVO or the 6 month treatment period of CRUISE.

Ranibizumab (0.5 mg)

In this extension study participants received Ranibizumab 0.5 mg intravitreal injection administered as needed no more frequently than every 30 days (no more than 12 injections per year) up to 24 months. Participants in this group received intravitreal sham injections in the 6 month treatment period of BRAVO and received ranibizumab in the 6 month observation period of BRAVO or in this extension study.

Ranibizumab (Sham BRAVO)

In this extension study participant received Ranibizumab 0.5 mg intravitreal injection administered as needed no more frequently than every 30 days (no more than 12 injections per year) up to 24 months. Participants in this group received 0.3 mg Ranibizumab intravitreal injections in the 6 month treatment period of BRAVO.

Ranibizumab (0.3 mg BRAVO)

In this extension study participants received Ranibizumab 0.5 mg intravitreal injection administered as needed no more frequently than every 30 days (no more than 12 injections per year) up to 24 months. Participants in this group received 0.5 mg Ranibizumab intravitreal injections in the 6 month treatment period of BRAVO.

Ranibizumab (0.5 mg BRAVO)

In this extension study participants received Ranibizumab 0.5 mg intravitreal injection administered as needed no more frequently than every 30 days (no more than 12 injections per year) up to 24 months. Participants in this group received intravitreal sham injections in the 6 month treatment period of CRUISE and received ranibizumab in the 6 month observation period of CRUISE or in this extension study.

Ranibizumab (Sham CRUISE)

In this extension study participants received Ranibizumab 0.5 mg intravitreal injection administered as-needed no more frequently than every 30 days (no more than 12 injections per year) up to 24 months. Participants in this group received 0.3 mg Ranibizumab intravitreal injections in the 6 month treatment period of CRUISE.

Ranibizumab (0.3 mg CRUISE)

In this extension study participants received Ranibizumab 0.5 mg intravitreal injection administered as-needed no more frequently than every 30 days (no more than 12 injections per year) up to 24 months. Participants in this group received 0.5 mg Ranibizumab intravitreal injections in the 6 month treatment period of CRUISE.

Ranibizumab (0.5 mg CRUISE)

Total

<45 years

45 to <65 years

65 to <85 years

≥85 years

Age, Customized

Sex: Female, Male

Genentech

Any ocular adverse event (AE)

Ocular AE leading to treatment discontinuation

Ocular serious adverse event

Intraocular inflammation

Cataract

In this extension study participants received Ranibizumab 0.5 mg intravitreal injection administered as-needed no more frequently than every 30 days (no more than 12 injections per year) up to 24 months. Participants in this group received intravitreal sham injections in the 6 month treatment period of BRAVO and received ranibizumab in the 6 month observation period of BRAVO or in this extension study.

In this extension study participants received Ranibizumab 0.5 mg intravitreal injection as-needed administered no more frequently than every 30 days (no more than 12 injections per year) up to 24 months. Participants in this group received 0.3 mg Ranibizumab intravitreal injections in the 6 month treatment period of BRAVO.

In this extension study participants received Ranibizumab 0.5 mg intravitreal injection as-needed administered no more frequently than every 30 days (no more than 12 injections per year) up to 24 months. Participants in this group received 0.5 mg Ranibizumab intravitreal injections in the 6 month treatment period of BRAVO.

In this extension study participants received Ranibizumab 0.5 mg intravitreal injection administered as-needed no more frequently than every 30 days (no more than 12 injections per year) up to 24 months. Participants in this group received sham intravitreal injections in the 6 month treatment period of CRUISE and received ranibizumab in the 6 month observation period of CRUISE or in this extension study.

In this extension study participants received Ranibizumab 0.5 mg intravitreal injection as-needed administered no more frequently than every 30 days (no more than 12 injections per year) up to 24 months. Participants in this group received 0.5 mg Ranibuzumab intravitreal injections in the 6 month treatment period of CRUISE.

Ranibizumab- Treated Participants includes all participants who received Ranibizumab in one of the initial studies or this extension study. This analysis includes only those adverse events that occurred during this extension study.

Number of Participants With Ocular Adverse Events in the Study Eye

Any non-ocular adverse event

Serious non-ocular adverse event

Non-ocular adverse event led to discontinuation

Death

Number of Participants With Non-ocular Adverse Events

Month 6 (n=88,96,98,90,101,91)

Month 12 (n=66,66,73,58,69,50)

Month 18 (n=23,26,32,31,26,22)

Month 24 (n=0,2,0,0,1,0)

Enrolled participants for whom data was available for analyses at the given time-points. Observed data were used with no imputation. The number of participants for whom data was available for analyses is represented by "n".

Change From Baseline in the Best Corrected Visual Acuity (BCVA)

Month 6 (n=86,96,97,90,101,89)

Month 12 (n=62,65,72,56,69,51)

Enrolled participants for whom data was available for analyses at the given time-point as indicated by "n" in the categories. Observed data were used with no imputation.

Change From Baseline in Central Foveal Thickness at Month 6 and Month 12

Month 12 (n=64,65,72,58,67,50)

In this extension study participants received Ranibizumab 0.5 mg intravitreal injection administered as-needed no more frequently than every 30 days (no more than 12 injections per year) for 24 months. Participants in this group received intravitreal sham injections in the 6 month treatment period of BRAVO and received ranibizumab in the 6 month observation period of BRAVO or in this extension study.

In this extension study participants received Ranibizumab 0.5 mg intravitreal injection as-needed administered no more frequently than every 30 days (no more than 12 injections per year) for 24 months. Participants in this group received 0.3 mg Ranibizumab intravitreal injections in the 6 month treatment period of BRAVO.

In this extension study participants received Ranibizumab 0.5 mg intravitreal injection as-needed administered no more frequently than every 30 days (no more than 12 injections per year) for 24 months. Participants in this group received 0.5 mg Ranibizumab intravitreal injections in the 6 month treatment period of BRAVO.

In this extension study participants received Ranibizumab 0.5 mg intravitreal injection administered as-needed no more frequently than every 30 days (no more than 12 injections per year)for 24 months. Participants in this group received sham intravitreal injections in the 6 month treatment period of CRUISE and received ranibizumab in the 6 month observation period of CRUISE or in this extension study.

In this extension study participants received Ranibizumab 0.5 mg intravitreal injection administered as-needed no more frequently than every 30 days (no more than 12 injections per year) for 24 months. Participants in this group received 0.3 mg Ranibizumab intravitreal injections in the 6 month treatment period of CRUISE.

In this extension study participants received Ranibizumab 0.5 mg intravitreal injection as-needed administered no more frequently than every 30 days (no more than 12 injections per year) for 24 months. Participants in this group received 0.5 mg Ranibuzumab intravitreal injections in the 6 month treatment period of CRUISE.

Change From Baseline in Visual Function Composite Score, as Measured by the National Eye Institute Visual Function Questionnaire-25 (NEI VFQ-25)

In this extension study participants received Ranibizumab 0.5 mg intravitreal injection administered as-needed no more frequently than every 30 days (no more than 12 injections per year) up to 24 months. Participants in this group received 0.3 mg Ranibizumab intravitreal injections in the 6 month treatment period of BRAVO.

In this extension study participants received Ranibizumab 0.5 mg intravitreal injection administered as-needed no more frequently than every 30 days (no more than 12 injections per year) up to 24 months. Participants in this group received 0.5 mg Ranibizumab intravitreal injections in the 6 month treatment period of BRAVO.

In this extension study participants received Ranibizumab 0.5 mg intravitreal injection administered as-needed no more frequently than every 30 days (no more than 12 injections per year) up to 24 months. Participants in this group received intravitreal sham injections in the 6 month treatment period of CRUISE and received ranibizumab in the 6 month observation period of CRUISE or in this extension study.

Overall Study

Skin and Connective Tissue Diseases

Rare Diseases

Melanoma

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Nerve Tissue

Nevus, Pigmented

Nevus

Nevi and Melanomas

Skin Neoplasms

Skin Diseases

Neuroendocrine Tumor

Neuroepithelioma

Intravitreal injection of ranibizumab (0.5mg) once a month for 6 months and transpupillary thermotherapy enhanced with Indocyanine Green (ICG) dye, once or twice starting at 2nd month.

Ranibizumab injection and TTT - ICG based

To report preliminary results on safety and tolerability of intravitreal injection of Ranibizumab (Lucentis) combined with Transpupillary Thermotherapy (TTT)+ Indocyanine Green (ICG)-based photodynamic therapy (PDT) in the treatment of choroidal melanoma.

Lucentis as an Adjuvant Therapy With TTT-ICG Based in Choroidal Melanoma

Ranibizumab as Adjuvant Therapy for the Treatment of Choroidal Melanoma

New England Retina Associates

Adverse event data are not available to be reported because the PI left the institution and adverse event data in the required format is unavailable.

Intravitreal injection of ranibizumab (0.5mg) once a month for 6 months and transpupillary thermotherapy enhanced with Indocyanine Green (ICG) dye, once or twice starting at 2nd month.

Ranibizumab injection and TTT - ICG based: Intravitreal injection of ranibizumab (0.5mg) once a month for 6 months and transpupillary thermotherapy enhanced with Indocyanine Green (ICG) dye, once or twice starting at 2nd month.

Lucentis Injection

Age, Categorical

Baseline Data available for 8 participants

Dr. Peter Liggett

Mean Tumor Thickness

PI has left the institution and summary data are not available.

Visual Acuity Changes

Choroid Diseases

Intraocular Melanoma

Anti-Inflammatory Agents

Triamcinolone

Triamcinolone Acetonide

Triamcinolone hexacetonide

Triamcinolone diacetate

Glucocorticoids

Hormones

Hormone Antagonists

Immunosuppressive Agents

Immunologic Factors

Enzyme Inhibitors

three initial monthly intra vitreal injections with 0.5 mg ranibizumab

ranibizumab

at baseline one intra vitreal injection with 4.0 mg triamcinolone acetonide

triamcinolone acetonide

sham

Martine J Jager, MD, PhD

The purpose of this study is to demonstrate a statistically significant improvement of visual acuity after treatment using either Lucentis® or Triamcinolone® compared to no treatment, in patients with radiation retinopathy.

Approximately 30-40% of patients develop a deterioration of visual acuity within 5 years after treatment of uveal melanoma using radiation therapy and TTT due to radiation retinopathy (Shields 2002, Bartlema 2003). By administration of either Lucentis® or Triamcinolone® we hope to treat complications of radiation therapy, by demonstrating a statistically significant improvement in visual acuity and a reduced amount of macular edema and vascular leakage. Additionally, we hope to obtain a better understanding of the pathophysiologic processes involved, by demonstrating a possible relation between high levels of angiogenic factors (VEGF) in the anterior chamber fluid, and radiation retinopathy. In conclusion, we hope to provide evidence for a new therapy in patients with retinopathy, due to radiation in uveal melanoma. There is no scientifically proven treatment available at this time.

Treatment Of Radiation Retinopathy Trial

Treatment Of Radiation Retinopathy Trial Subtitle: Treatment of Radiation Retinopathy; Influence of Lucentis® and Kenalog® on Radiation Retinopathy After Irradiation of Choroidal Melanoma.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
An Extension Study to Evaluate Safety and Tolerability of Ranibizumab in Macular Edema Secondary to Retinal Vein Occlusion (Cohort 2)	NCT01442064	Macular Edema Retinal Vein Oc...	Ranibizumab 0.5...	18 Years -	Genentech, Inc.
An Extension Study to Evaluate Safety and Tolerability of Ranibizumab in Macular Edema Secondary to Retinal Vein Occlusion (Cohort 2)	NCT01442064	Macular Edema Retinal Vein Oc...	Ranibizumab 0.5...	18 Years -	Genentech, Inc.
Lucentis as an Adjuvant Therapy With TTT-ICG Based in Choroidal Melanoma	NCT00680225	Choroidal Melan...	Ranibizumab inj...	18 Years - 90 Years	New England Retina Associates
Treatment Of Radiation Retinopathy Trial	NCT00811200	Uveal Melanoma	ranibizumab triamcinolone a... sham	18 Years -	Leiden University Medical Center

Spots Global Cancer Trial Database for lucentis

Every month we try and update this database with for lucentis cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for lucentis

Every month we try and update this database with for lucentis cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for lucentis cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.