Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Eye Diseases

Behaviors and Mental Disorders

Digestive System Diseases

Prostatic Neoplasms

Cognitive Dysfunction

Colorectal Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Cognition Disorders

Neurocognitive Disorders

Mental Disorders

Psychotic Disorders

Micronutrients

All Drugs and Chemicals

Vitamins

Ascorbic Acid

Tocopherols

Vitamin E

Tocotrienols

alpha-Tocopherol

Carotenoids

Beta Carotene

Trace Elements

Antioxidants

Protective Agents

Provitamins

Vitamin C

Tocopherol

Tocotrienol

400 IU synthetic alpha-tocopherol or its placebo on alternate days (provided by BASF)

500 mg synthetic ascorbic acid or its placebo daily (provided by BASF)

Centrum Silver or its placebo daily (provided by Pfizer (formerly Wyeth, American Home Products, and Lederle))

Multivitamin

50 mg Lurotin or placebo on alternate days (provided by BASF)

Beta-carotene

J. Michael Gaziano, MD, MPH

The use of vitamin E, vitamin C, beta carotene, and/or multivitamins may keep cancer, cardiovascular disease, eye diseases, or cognitive decline from occurring. This randomized clinical trial studied vitamin E, vitamin C, beta carotene, and/or multivitamins to see how well they work compared with placebos in preventing cancer, cardiovascular disease, eye disease, and cognitive decline in male doctors aged 50 years and older.

OBJECTIVES:

Primary

* To determine whether vitamin E every other day reduces the risk of developing prostate cancer in older healthy male physicians.
* To determine whether daily vitamin C and/or a multivitamin reduces the risk of total cancer in these participants.
* To determine whether vitamin E every other day, vitamin C daily, or a multivitamin daily reduces the risk of major cardiovascular events in these participants.

Secondary

* To determine whether vitamin E and/or multivitamins reduce the risk of developing total cancer, colon cancer, and colon polyps in these participants.
* To determine whether vitamin E, vitamin C, or multivitamins reduce the risk of myocardial infarction and stroke in these participants.
* To determine whether vitamin E, vitamin C, or multivitamins reduce the risk of age-related macular degeneration or cataract in these participants.
* To determine whether vitamin E, vitamin C, or multivitamins reduce the risk of early cognitive decline in participants aged 65 and over.

The Physicians' Health Study II was a randomized, double-blind, placebo-controlled, factorial trial that began in 1997 and ended in 2011. It was designed to test four supplements -- (1) alternate-day vitamin E (400 international units of synthetic alpha-tocopherol) or its placebo; (2) daily vitamin C (500 mg synthetic ascorbic acid) or its placebo; (3) a daily multivitamin (Centrum Silver) or its placebo; and (4) alternate-day beta carotene (50 mg Lurotin) or its placebo -- in the prevention of cancer, cardiovascular disease, eye disease, and early cognitive decline among 14,641 male physicians aged 50 years or older. Participants were randomly assigned in a 2x2x2x2 factorial trial to receive combinations of the four active supplements or their placebos. Pills and/or packaging were provided by BASF Corporation, Pfizer (formerly Wyeth, American Home Products, and Lederle), and DSM Nutritional Products (formerly Roche Vitamins).

The beta-carotene component was discontinued on March 8, 2003; the vitamin E and vitamin C components ended as scheduled on August 31, 2007; and the multivitamin component ended on June 1, 2011.

Physicians' Health Study II

Physicians' Health Study II: Trial of Vitamins in the Chemoprevention of Cancer, CVD, and Eye Disease

National Cancer Institute (NCI)

Brigham and Women's Hospital

Physician, Brigham and Women's Hospital; Professor of Medicine, Harvard Medical School

Skin and Connective Tissue Diseases

Rare Diseases

Carcinoma

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

Conjunctival Melanoma

Neuroendocrine Tumor

Neuroepithelioma

Intraoperative lymphatic mapping, then biopsy/removal of the conjunctiva/eyelid tumor.

Sentinel Lymph Node Mapping and Biopsy

Bita Esmaeli, MD

The goal of this clinical research study is to find the sentinel lymph node (SLN) (s) and biopsy it (them) to see if the patient has small or low volume metastatic disease that would otherwise have been missed.

You have had your conjunctival or eyelid tumor surgically removed or it is scheduled to have it removed. You will have lymphatic mapping before the tumor is removed. Lymphatic mapping is when a small volume of Tc99m-Sulfur colloid is injected by an ophthalmologist after which some radiologic images are taken.

If you are able to become pregnant, blood (about 2 teaspoons) will be drawn for a pregnancy test, within 7 days before the biopsy. To take part in this study, you must not be pregnant.

You will then go to the operating room and have intraoperative SLN mapping and biopsy. If the SLN is positive on permanent section, you will go on to have complete lymph node dissection, which involves removal of all the lymph nodes around the positive SLN. Then the disease will be restaged and you may require further treatment after consultation with their oncologist.

Your medical record will be reviewed, and information from your medical record will be recorded and reviewed to help researchers better identify those patients who have microscopic lymph node disease. The information collected from your medical records will include information about your sex, age, what type of cancer that you have, as well as the size of the cancer and its location.

Researchers hope to identify those patients who have microscopic lymph node disease before it becomes clinically obvious. With this technique, researchers could potentially identify occult metastatic disease which would otherwise go unnoticed until it was too advanced. Patients in this study will have to see the ophthalmologist every three months and have the usual metastatic workup, which is routine for conjunctival/eyelid melanoma.

Length of Study:

Your active participation on this study will be over once the biopsy is over. You will continue to be observed on study for 5 years after the biopsy.

Long-Term Follow-Up:

Every 3 months for the first year after the biopsy, and every 6 months after that until 5 years after the biopsy, you will have an eye exam to check the status of the disease.

Every 6 months for the first year after the biopsy, blood (less than 1 teaspoon) will be drawn for liver function tests. You will also have a chest x-ray. You will then have these tests 1 time each year for 5 years after the biopsy.

You will have a head and neck CT or MRI every 6 months for the first year after the biopsy to make sure the disease has not come back. The head and neck CT or MRI will be repeated 1 time each year for 5 years after the biopsy.

This is an investigational study. A total of 38 patients will take part in this study. All will be enrolled at MD Anderson Cancer Center.

Sentinel Lymph Node (SLN) Biopsy for Conjunctival/Eyelid Melanoma

Sentinel Lymph Node Localization and Biopsy for Conjunctival and Eyelid Melanoma

The frequency of lymphatic drainage basins for bulbar versus palpebral conjunctiva and for nasal and the temporal quadrants estimated with 95% confidence intervals. The rate of identification of SLN evaluated with a confidence interval. The probability of positive SLN in primary conjunctival and eyelid melanoma estimated.

M.D. Anderson Cancer Center

Symptoms and General Pathology

Nervous System Diseases

Neoplasm Metastasis

Myopia

Retinal Diseases

Neovascularization, Pathologic

Vision, Low

Myopia, Degenerative

Choroidal Neovascularization

Vision Disorders

Neoplastic Processes

Refractive Errors

Metaplasia

Choroid Diseases

Uveal Diseases

Sensation Disorders

Neurologic Manifestations

Antineoplastic Agents

Angiogenesis Inhibitors

Ranibizumab

Growth Inhibitors

Patients treated with a single ranibizumab 0.5 mg/0.05ml intravitreal injection

All patients received a single initial intravitreal injection of ranibizumab 0.5 mg/0.05 ml as per Committee for Human Medicinal Products (CHMP)approval. Further injections might have been required when monitoring reveals disease activity. Disease activity, defined as reduced visual acuity and/or signs of lesion activity, was evaluated based on clinical examination (BCVA, fundus), and/or optical coherence tomography (OCT), and/or fluorescein angiography (FAG). Bilateral treatment was allowed provided at least 14 days of intercurrence.

Novartis Pharmaceuticals

The primary objective of the study was to investigate current criteria driving re-treatment in patients affected by Choroidal Neovascularization (CNV) secondary to Pathologic Myopia (PM) and experiencing a relapse of the disease after the first administration of ranibizumab.

A Study of the Criteria Establishing the Need for Re-treatment With Ranibizumab Upon Relapse in Patients With Visual Impairment Due to Choroidal Neovascularization Secondary to Pathologic Myopia.

A 12-month, Open-label, Interventional, Multicentre Study to Investigate the Current Criteria Driving Re-treatment With Ranibizumab Upon Relapse in Patients With Visual Impairment Due to Choroidal Neovascularization Secondary to Pathologic Myopia

Presence of active leakage on fluorescein angiography (FAG) was assessed at screening (14 to 3 days before baseline visit), month 2 and month 6. A univariate logistic regression model was applied expressing the presence/absence of the first retreatment in function of presence of active leakage (Yes/No). For retreated patients, the presence/absence of active leakage was considered at the closest time-point to the first re-treatment: the last scheduled assessment immediately before the first re-treatment was considered. For treated patients, the last scheduled assessment available was considered. In case of missing value on the scheduled assessment, the value was considered as missing for this analysis. \*NE = Not evaluable

Presence of macular edema from optical coherence tomography (OCT) was assessed at screening (14 to 3 days before baseline visit), month 2, month 6 and month 12. A univariate logistic regression model was applied expressing the presence/absence of the first retreatment in function of presence of macular edema (Yes/No). For retreated patients, the presence/absence of macular edema was considered at the closest time-point to the first re-treatment: the last scheduled assessment immediately before the first re-treatment was considered. For treated patients, the last scheduled assessment available was considered. In case of missing value on the scheduled assessment, the value was considered as missing for this analysis. \*NE = Not evaluable

Presence of cysts from optical coherence tomography (OCT) was assessed at screening (14 to 3 days before baseline visit), month 2, month 6 and month 12. A univariate logistic regression model was applied expressing the presence/absence of the first retreatment in function of presence of cysts (Yes/No). For retreated patients, the presence/absence of cysts was considered at the closest time-point to the first re-treatment: the last scheduled assessment immediately before the first re-treatment was considered. For treated patients, the last scheduled assessment available was considered. In case of missing value on the scheduled assessment, the value was considered as missing for this analysis. \*NE = Not evaluable

Presence of Intra-retinal fluid from optical coherence tomography (OCT) was assessed at screening (14 to 3 days before baseline visit), month 2, month 6 and month 12. A univariate logistic regression model was applied expressing the presence/absence of the first retreatment in function of presence of Intra-retinal fluid (Yes/No). For retreated patients, the presence/absence of Intra-retinal fluid was considered at the closest time-point to the first re-treatment: the last scheduled assessment immediately before the first re-treatment was considered. For treated patients, the last scheduled assessment available was considered. In case of missing value on the scheduled assessment, the value was considered as missing for this analysis. \*NE = Not evaluable

Central subfield thickness (CSFT) from optical coherence tomography (OCT) was assessed at screening (14 to 3 days before baseline visit), month 2, month 6 and month 12. A univariate logistic regression model was applied expressing the presence/absence of the first retreatment in function of change in CSFT versus previous visit. For retreated patients, the change in CSFT was considered at the closest time-point to the first re-treatment: the last scheduled assessment immediately before the first re-treatment was considered. For treated patients, the last scheduled assessment available was considered. In case of missing value on the scheduled assessment, the value was considered as missing for this analysis.

Central subfield volume (CSV) from optical coherence tomography (OCT) was assessed at screening (14 to 3 days before baseline visit), month 2, month 6 and month 12. A univariate logistic regression model was applied expressing the presence/absence of the first retreatment in function of change in CSV versus previous visit. For retreated patients, the change in CSV was considered at the closest time-point to the first re-treatment: the last scheduled assessment immediately before the first re-treatment was considered. For treated patients, the last scheduled assessment available was considered. In case of missing value on the scheduled assessment, the value was considered as missing for this analysis.

Presence of sub-retinal fluid from optical coherence tomography (OCT) was assessed at screening (14 to 3 days before baseline visit), month 2, month 6 and month 12. The regression model for sub-retinal fluid was not valid because "Yes" was reported in almost all subjects causing a quasi-complete separation of data points. \*NE = Not evaluable

Presence of clinically significant abnormalities was assessed at baseline, month 1, month 2, month 3, month 6 and month 12. A univariate logistic regression model was applied expressing the presence/absence of the first retreatment in function of presence of clinically significant abnormalities (Yes/No). For retreated patients, the presence/absence of clinically significant abnormalities was considered at the closest time-point to the first re-treatment: the last scheduled assessment immediately before the first re-treatment was considered. For treated patients, the last scheduled assessment available was considered. In case of missing value on the scheduled assessment, the value was considered as missing for this analysis.

Improvement in BCVA \< 5 letters (Yes/No) was assessed at month1, month 2, month 3, month 6 and month 12. A univariate logistic regression model was applied expressing the presence/absence of the first retreatment in function of improvement in BCVA \< 5 letters (Yes/No) which was reported as Gain \>= 5 letters versus Gain \< 5 letters. For retreated patients, Gain \>= 5 letters and Gain \< 5 letters were considered at the closest time-point to the first re-treatment: the last scheduled assessment immediately before the first re-treatment was considered. For treated patients, the last scheduled assessment available was considered. In case of missing value on the scheduled assessment, the value was considered as missing for this analysis.

Improvement in BCVA \< 10 letters (Yes/No) was assessed at month1, month 2, month 3, month 6 and month 12. A univariate logistic regression model was applied expressing the presence/absence of the first retreatment in function of improvement in BCVA \< 10 letters (Yes/No) which was reported as Gain \>= 10 letters versus Gain \< 10 letters. For retreated patients, Gain \>= 10 letters and Gain \< 10 letters were considered at the closest time-point to the first re-treatment: the last scheduled assessment immediately before the first re-treatment was considered. For treated patients, the last scheduled assessment available was considered. In case of missing value on the scheduled assessment, the value was considered as missing for this analysis.

Changes from baseline in BCVA are described for the ETDRS parameter considering the following categories at each assessment: "no change" if the change was equal to 0 letter, "worsening" if change \< 0 letter , "improvement" if change \> 0 letter. A univariate logistic regression model was applied expressing the presence/absence of the first retreatment in function of change from baseline in BCVA (improved/worsened/stable) which was reported as Improved versus no change and worsened versus no change. For retreated patients, this variable was considered at the closest time-point to the first re-treatment: the last scheduled assessment immediately before the first re-treatment was considered. For treated patients, the last scheduled assessment available was considered. In case of missing value on the scheduled assessment, the value was considered as missing for this analysis.

Change from baseline in BCVA (Best Corrected Visual Acuity) was Measured by Early Treatment Diabetic Retinopathy Study (ETDRS) Letter Score. Patients with a BCVA ETDRS letter score of 78 to 24 in the study eye were included; A higher score represents better functioning of the study eye. A positive change from baseline shows improvement.

Mean number of ranibizumab injection is reported as number of injections per patient.

Time to re-treatment, defined as time in months from the data of first dose of ranibizumab to the date of re-treatment, was evaluated.

Number of patients with any systemic AE, with serious systemic AE, with an ocular AE, with an ocular serious AE are reported

Patient quality of life was assessed by Impact of Vision Impairment (IVI) questionnaire. IVI is a 32-item instrument, either self- or interviewer-administered, developed to measure the impact of vision impairment on daily activities in five domains. The 32 items were divided into 5 domains as follows: Leisure and work (items 1 to 5), Social and consumer interaction (items 6 to 10 and items 23-24), Household and personal care (items 11 to 14 and items 20-21), Mobility (items 15 to 19 and item 22), Emotional reaction to vision loss (items 25 to 32). Responses to the IVI items were rated on a five-category Likert scale: not at all, 0; hardly at all, 1; a little, 2; a fair amount, 3; a lot, 4; and can't do because of eyesight, 5. Total score was an arithmetic average of the items rated between 0 (the best score) and 5 (the worst score). A negative change indicates improvement. Data was computed on items with non missing response

Safety Population: All subjects who received at least one dose of ranibizumab and had at least one post-baseline safety assessment.

All subjects who received at least one dose of ranibizumab and had at least one post-baseline safety assessment.

Patients treated only once with a single ranibizumab 0.5 mg/0.05ml intravitreal injection.

Ranibizumab: Treated Once

Patients treated more than once with a single ranibizumab 0.5 mg/0.05ml intravitreal injection.

Ranibizumab: Re-treated Once

Total

Age, Continuous

Sex: Female, Male

Full Analysis Set (FAS): All subjects who received at least one dose of ranibizumab

Study Director

Screening: Active leakage, No

Screening: Active leakage, Yes

Screening: Active leakage, NE

Screening: Active leakage, Missing

Month 2: Active leakage, No

Month 2: Active leakage, Yes

Month 2: Active leakage, NE

Month 6: Active leakage, No

Month 6: Active leakage, Yes

Month 6: Active leakage, NE

Full Analysis Set (FAS): all patients who received at least one dose of ranibizumab and underwent fluorescein angiography at that time point.

Number of Patients Treated and Re-treated Based on Presence/Absence of Active Leakage

Change at 6 month

Change at 12 month

Patients treated with a single ranibizumab 0.5 mg/0.05ml intravitreal injection. Further injections might be required when monitoring reveals disease activity.

Full Analysis Set (FAS): all patients who received at least one dose of ranibizumab. The study eyes of the patients belonging to the FAS were analyzed.

Mean Change in Best Corrected Visual Acuity (BCVA) From Baseline to Month 6 and Month 12 on Study Eye

Full Analysis Set (FAS): all subjects who received at least one dose of ranibizumab

Mean Number of Ranibizumab Injection

Time to Re-treatment

Any systemic Adverse Event

Serious systemic Adverse Event

Ocular Adverse Event

Ocular serious adverse event

Safety Population: all subjects who received at least one dose of ranibizumab and had at least one post-baseline safety assessment.

Number of Patients Having Ocular and/or Systemic Adverse Event (AE)

Change at Month 2

Change at month 12

Full Analysis Set (FAS): all subjects who received at least one dose of ranibizumab with data at both timepoints.

Change in Patient Quality of Life From Baseline to Month 2 and Month 12

Screening: Macular Edema, No

Screening: Macular Edema, Yes

Screening: Macular Edema, NE

Month 2: Macular Edema, No

Month 2: Macular Edema, Yes

Month 2: Macular Edema, NE

Month 6: Macular Edema, No

Month 6: Macular Edema, Yes

Month 6: Macular Edema, NE

Month 12: Macular Edema, No

Month 12: Macular Edema, Yes

Month 12: Macular Edema, NE

Full Analysis Set (FAS): all patients who received at least one dose of ranibizumab and underwent OCT at that time point.

Number of Patients Treated and Re-treated Based on Presence/Absence of Macular Edema

Screening: Cysts, No

Screening: Cysts, Yes

Screening: Cysts, NE

Month 2: Cysts, No

Month 2: Cysts, Yes

Month 2: Cysts, NE

Month 2: Cysts, Missing

Month 6: Cysts, No

Month 6: Cysts, Yes

Month 6: Cysts, NE

Month 12: Cysts, No

Month 12: Cysts, Yes

Month 12: Cysts, NE

Number of Patients Treated and Re-treated Based on Presence/Absence of Cysts

Presence vs. absence of intra-retinal fluid.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Physicians' Health Study II	NCT00270647	Cancer Prostate Cancer Colorectal Canc... Cardiovascular ... Eye Disease Cognitive Decli...	Vitamin E Vitamin C Multivitamin Beta-carotene	50 Years -	Brigham and Women's Hospital
Sentinel Lymph Node (SLN) Biopsy for Conjunctival/Eyelid Melanoma	NCT00386906	Eye Disease Melanoma	Sentinel Lymph ...	18 Years -	M.D. Anderson Cancer Center
A Study of the Criteria Establishing the Need for Re-treatment With Ranibizumab Upon Relapse in Patients With Visual Impairment Due to Choroidal Neovascularization Secondary to Pathologic Myopia.	NCT02034006	Choroidal Neova...	Ranibizumab	18 Years -	Novartis
Sentinel Lymph Node (SLN) Biopsy for Conjunctival/Eyelid Melanoma	NCT00386906	Eye Disease Melanoma	Sentinel Lymph ...	18 Years -	M.D. Anderson Cancer Center

Spots Global Cancer Trial Database for eye disease

Every month we try and update this database with for eye disease 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 eye disease

Every month we try and update this database with for eye disease 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 eye disease 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.