## Protocol Section
### Identification Module
**NCT ID:** NCT00896779

**Brief Title:** Lucentis in Advanced Macular Degeneration

**Official Title:** Lucentis in Advanced Macular Degeneration

#### Organization Study ID Info
**ID:** SU-04202009-2338
#### Organization
**Class:** OTHER
**Full Name:** Stanford University
### Status Module
#### Completion Date
**Date:** 2013-09

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2015-06-29

**Type:** ESTIMATED

**Last Update Submit Date:** 2015-06-01

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2013-09

**Type:** ACTUAL

#### Results First Post Date
**Date:** 2015-05-27

**Type:** ESTIMATED

**Results First Submit Date:** 2015-05-07

**Results First Submit QC Date:** 2015-05-07

#### Start Date
**Date:** 2009-10

**Status Verified Date:** 2015-06

#### Study First Post Date
**Date:** 2009-05-12
**Type:** ESTIMATED
**Study First Submit Date:** 2009-05-08
**Study First Submit QC Date:** 2009-05-11
### Sponsor Collaborators Module

#### Collaborators

**Class:** INDUSTRY

**Name:** Genentech, Inc.

**Class:** OTHER

**Name:** California Pacific Medical Center

**Class:** OTHER

**Name:** Pacific Eye Associates

#### Lead Sponsor

**Class:** OTHER

**Name:** Steven R. Sanislo

#### Responsible Party

**Investigator Affiliation:** Stanford University

**Investigator Full Name:** Steven R. Sanislo

**Investigator Title:** MD/PI

**Type:** SPONSOR_INVESTIGATOR

### Oversight Module

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** Patients with low vision (visual acuity 20/400 or worse) were excluded from the large Phase III ranibizumab clinical trials. It is not known if treatment with ranibizumab results in improved visual function in such patients.Since ranibizumab has been shown to be the most effective therapy for exudative macular degeneration we propose to treat all patients in this study with monthly ranibizumab intravitreal injections.

Patients will be assigned to one of two groups by the flip of a coin. Group #1 for "heads" and Group #2 for "tails".

Group #1 patients will be treated for 3 monthly injections of 0.5 mg of ranibizumab and then as needed therapy.

Group #2 will be treated with 6 monthly injections of 0.5 mg of ranibizumab and then as needed therapy.

**Detailed Description:** The duration of the study is up to 13 months. This includes up to 30 days during which tests will be performed before treatment. Only one eye will be chosen for the study. Patients can receive up to 12 injections of ranibizumab during this study (the first dose\[s\], plus additional doses \[re treatment as often as every 22 days\] if the doctor determines that additional doses are required).

In addition to study drug injections. Several eye examinations and procedures will be performed to evaluate response to treatment. These include: visual acuity testing (eye chart), contrast sensitivity testing, reading speed testing, measurement of time to complete typical daily activities, measurement of the thickness of the central retina, measurement of your central visual field.

On the screening visit and two more times during the study fluorescein angiography will be performed.

The screening tests included the following:

* A review of your medical history
* A review of any medications you are or have been taking
* Eye examinations, including visual acuity testing (reading letters on an eye chart)
* Blood pressure measurement Woman of childbearing potential must also take a urine pregnancy test during the screening period to rule out pregnancy.

Upon completion of the study at Month 12 and if it were to occur; early termination visit, the following procedures will be performed: vision exam,OCT,microperimetry,FA/Photos,VFQ,reading performance, contrast sensitivity and TIADL.

### Conditions Module

**Conditions:**

- Macular Degeneration

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 20

**Type:** ACTUAL

**Phases:**

- PHASE2

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Group 1: 3 monthly injections of 0.5mg then prn

**Intervention Names:**

- Drug: ranibizumab

**Label:** ranibizumab Group 1

**Type:** OTHER

#### Arm Group 2

**Description:** Group 2: 6 monthly injections of 0.5 mg then prn

**Intervention Names:**

- Drug: ranibizumab

**Label:** ranibizumab Group 2

**Type:** OTHER

### Interventions

#### Intervention 1

**Arm Group Labels:**

- ranibizumab Group 1

- ranibizumab Group 2

**Description:** Group 1 - 0.5mg intravitreal injection every month for 3 months then as needed for 12 months

Group 2 -0.5mg intravitreal injection every month for 6 months then as needed for 12 months

**Name:** ranibizumab

**Other Names:**

- Lucentis

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Description:** Change in vision from baseline measurement at 12 months. Standard ETDRS chart (80 letters) was used to determine visual acuity with test luminance of 45 cd/m \^2 at 8 feet. Number of correctly read letters were reported.

**Measure:** Mean Change in Visual Acuity

**Time Frame:** 12 months

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

Subjects will be eligible if the following criteria are met:

* Ability to provide written informed consent and comply with study assessments for the full duration of the study.
* Age \> 50 years.
* Low vision AMD patients with a VA of 20/400 or worse.
* Evidence of active exudation as manifested by subretinal or intraretinal fluid on OCT or fresh appearing subretinal hemorrhage on fundus examination.

Exclusion Criteria:

Subjects who meet any of the following criteria will be excluded from this study:

* Pregnancy (positive pregnancy test) or lactation.
* Premenopausal women not using adequate contraception. The following are considered effective means of contraception: surgical sterilization or use of oral contraceptives, barrier contraception with either a condom or diaphragm in conjunction with spermicidal gel, an IUD, or contraceptive hormone implant or patch.
* Any other condition that the investigator believes would pose a significant hazard to the subject if the investigational therapy were initiated.
* Participation in another simultaneous medical investigation or trial.
* Concurrent eye disease in the study eye that could compromise visual acuity (e.g., diabetic retinopathy, advanced glaucoma).

**Minimum Age:** 50 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** San Francisco

**Country:** United States

**Facility:** California Pacific Medical Center

**State:** California

**Zip:** 94107

**Location 2:**

**City:** Stanford

**Country:** United States

**Facility:** Stanford University School of Medicine

**State:** California

**Zip:** 94305

#### Overall Officials

**Official 1:**

**Affiliation:** Stanford University

**Name:** Dr. Steven R. Sanislo

**Role:** PRINCIPAL_INVESTIGATOR

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000012162

- Term: Retinal Degeneration

- ID: D000012164

- Term: Retinal Diseases

- ID: D000005128

- Term: Eye Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC11

- Name: Eye Diseases

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M11260

- Name: Macular Degeneration

- Relevance: HIGH

- As Found: Macular Degeneration

- ID: M14997

- Name: Retinal Degeneration

- Relevance: LOW

- As Found: Unknown

- ID: M14999

- Name: Retinal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M8271

- Name: Eye Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000008268

- Term: Macular Degeneration

### Intervention Browse Module - Ancestors

- ID: D000020533

- Term: Angiogenesis Inhibitors

- ID: D000043924

- Term: Angiogenesis Modulating Agents

- ID: D000006133

- Term: Growth Substances

- ID: D000045505

- Term: Physiological Effects of Drugs

- ID: D000006131

- Term: Growth Inhibitors

- ID: D000000970

- Term: Antineoplastic Agents

### Intervention Browse Module - Browse Branches

- Abbrev: ANeo

- Name: Antineoplastic Agents

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M472

- Name: Ranibizumab

- Relevance: HIGH

- As Found: Dysfunction

- ID: M22318

- Name: Angiogenesis Inhibitors

- Relevance: LOW

- As Found: Unknown

- ID: M9231

- Name: Growth Inhibitors

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000069579

- Term: Ranibizumab

### Misc Info Module

- Version Holder: 2024-05-24

## Results Section

### Adverse Events Module

#### Event Groups

**Group ID:** EG000

**Title:** Ranibizumab Group 1

**Description:** Group 1: 3 monthly injections of 0.5mg then prn

**ID:** EG000

**Other Num Affected:** 4

**Other Num at Risk:** 8

**Serious Number At Risk:** 8

**Title:** Ranibizumab Group 1

**Group ID:** EG001

**Title:** Ranibizumab Group 2

**Description:** Group 2: 6 monthly injections of 0.5 mg then prn

**ID:** EG001

**Other Num Affected:** 4

**Other Num at Risk:** 12

**Serious Number At Risk:** 12

**Title:** Ranibizumab Group 2

**Frequency Threshold:** 0

#### Other Events

**Term:** laceration right leg

**Organ System:** Skin and subcutaneous tissue disorders

**Source Vocabulary:** 

**Term:** laceration left leg

**Organ System:** Skin and subcutaneous tissue disorders

**Source Vocabulary:** 

**Term:** Mild pneumonia

**Organ System:** Respiratory, thoracic and mediastinal disorders

**Source Vocabulary:** 

**Term:** Seasonal allergies

**Organ System:** Immune system disorders

**Source Vocabulary:** 

**Term:** Worsening glaucoma - which eye was not specified

**Organ System:** Eye disorders

**Source Vocabulary:** 

**Term:** visual disturbance - fellow eye

**Organ System:** Eye disorders

**Source Vocabulary:** 

**Term:** development of choroidal neovascularization - fellow eye

**Organ System:** Eye disorders

**Source Vocabulary:** 

**Term:** bruised sturnum

**Notes:** Due to auto accident

**Organ System:** Musculoskeletal and connective tissue disorders

**Source Vocabulary:** 

**Term:** subconjuctival hemorrhage - treatment eye

**Organ System:** Eye disorders

**Source Vocabulary:** 

**Term:** intraretinal hemorrhage - treatment eye

**Organ System:** Eye disorders

**Source Vocabulary:** 

**Term:** vitamin D deficiency

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** 

**Term:** intestinal flu

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** 

**Term:** rash

**Organ System:** Skin and subcutaneous tissue disorders

**Source Vocabulary:** 

**Term:** pinched nerve

**Organ System:** Nervous system disorders

**Source Vocabulary:** 

**Term:** stroke

**Organ System:** Nervous system disorders

**Source Vocabulary:** 

**Term:** endophthalmitis - fellow eye

**Organ System:** Eye disorders

**Source Vocabulary:** 

**Term:** cold

**Organ System:** Immune system disorders

**Source Vocabulary:** 

**Term:** ache left eye - treatment eye

**Notes:** after injection procedure

**Organ System:** Eye disorders

**Source Vocabulary:** 

**Term:** corneal abrasion - both eyes

**Organ System:** Eye disorders

**Source Vocabulary:** 

**Time Frame:** 12 months

## Results Section - Baseline Characteristics Module

### Denomination Counts

**Group ID:** BG000

**Value:** 8

**Group ID:** BG001

**Value:** 12

**Group ID:** BG002

**Value:** 20

**Units:** Participants

### Group

**ID:** BG000

**Title:** Ranibizumab Group 1

**Description:** Group 1: 3 monthly injections of 0.5mg then prn

### Group

**ID:** BG001

**Title:** Ranibizumab Group 2

**Description:** Group 2: 6 monthly injecions of 0.5mg then prn

### Group

**ID:** BG002

**Title:** Total

**Description:** Total of all reporting groups

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 0

**Category Title:** <=18 years

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 0

**Category Title:** Between 18 and 65 years

#### Measurement

**Group ID:** BG000

**Value:** 8

#### Measurement

**Group ID:** BG001

**Value:** 12

#### Measurement

**Group ID:** BG002

**Value:** 20

**Category Title:** >=65 years

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Lower Limit:** 68

**Upper Limit:** 94

**Value:** 81

#### Measurement

**Group ID:** BG001

**Lower Limit:** 71

**Upper Limit:** 97

**Value:** 84

#### Measurement

**Group ID:** BG002

**Lower Limit:** 68

**Upper Limit:** 97

**Value:** 83

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 3

#### Measurement

**Group ID:** BG001

**Value:** 8

#### Measurement

**Group ID:** BG002

**Value:** 11

**Category Title:** Female

#### Measurement

**Group ID:** BG000

**Value:** 5

#### Measurement

**Group ID:** BG001

**Value:** 4

#### Measurement

**Group ID:** BG002

**Value:** 9

**Category Title:** Male

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 8

#### Measurement

**Group ID:** BG001

**Value:** 12

#### Measurement

**Group ID:** BG002

**Value:** 20

**Class Title:** United States

**Denomination Units Selected:** 

## Results Section - Baseline Characteristics Module

### Measure 1
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Age, Categorical
**Unit of Measure:** Participants
### Measure 2
**Dispersion Type:** FULL_RANGE
**Parameter Type:** MEAN
**Title:** Age, Continuous
**Unit of Measure:** years
### Measure 3
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Sex: Female, Male
**Unit of Measure:** Participants
### Measure 4
**Parameter Type:** NUMBER
**Title:** Region of Enrollment
**Unit of Measure:** participants
## Results Section - More Information Module
### Certain Agreement
### Limitations and Caveats
**Description:** Limitations include small number of subjects analyzed and no control group that were untreated.
### Point of Contact
**Email:** ssanislo@stanford.edu
**Organization:** Stanford University
**Phone:** 650-723-6995
**Title:** Steven Sanislo, MD
## Results Section - Outcome Measures Module
### Outcome Measure 1
#### Analysis
**CI Lower Limit:** 
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 
**CI Upper Limit:** 
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** 
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 0.02
**P-Value Comment:** 
**Parameter Type:** 
**Parameter Value:** 
**Statistical Comment:** 
**Statistical Method:** t-test, 2 sided
**Tested Non-Inferiority:** False
#### Analysis
**CI Lower Limit:** 
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 
**CI Upper Limit:** 
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** 
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 0.06
**P-Value Comment:** 
**Parameter Type:** 
**Parameter Value:** 
**Statistical Comment:** 
**Statistical Method:** t-test, 2 sided
**Tested Non-Inferiority:** False
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 14.2
- **Upper Limit:** 
- **Value:** 15.0
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 8.6
- **Upper Limit:** 
- **Value:** 5.6
**Title:** 
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Description:** Change in vision from baseline measurement at 12 months. Standard ETDRS chart (80 letters) was used to determine visual acuity with test luminance of 45 cd/m \^2 at 8 feet. Number of correctly read letters were reported.
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Reporting Status:** POSTED
**Time Frame:** 12 months
**Title:** Mean Change in Visual Acuity
**Type:** PRIMARY
**Unit of Measure:** letters
##### Group
**Description:** Group 1: 3 monthly injections of raibizumab 0.5mg then injections as needed for 12 months
**ID:** OG000
**Title:** Ranibizumab Group 1
##### Group
**Description:** Group 2: 6 monthly injections of raibizumab 0.5mg then injections as needed for 12 months
**ID:** OG001
**Title:** Ranibizumab Group 2
### Participant Flow Module
#### Group
**Description:** Group 1: 3 monthly injections of raibizumab 0.5mg then injections as needed for 12 months
**ID:** FG000
**Title:** Ranibizumab Group 1
#### Group
**Description:** Group 1: 6 monthly injections of raibizumab 0.5mg then injections as needed for 12 months
**ID:** FG001
**Title:** Ranibizumab Group 2
#### Period
**Title:** Overall Study
##### Milestone
**Type:** STARTED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 8
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 12
##### Milestone
**Type:** COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 8
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 11
##### Milestone
**Type:** NOT COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 0
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 1
**Has Results:** True