## Protocol Section
### Identification Module
**NCT ID:** NCT01334879

**Brief Title:** High Dose Intravitreal Ranibizumab for Recalcitrant Radiation Retinopathy

**Official Title:** High Dose (2.0mg) Intravitreal Ranibizumab for Recalcitrant Radiation Retinopathy

#### Organization Study ID Info
**ID:** FVF4981S
#### Organization
**Class:** OTHER
**Full Name:** The New York Eye Cancer Center
### Status Module
#### Completion Date
**Date:** 2012-11

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2014-10-02

**Type:** ESTIMATED

**Last Update Submit Date:** 2014-09-30

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2012-11

**Type:** ACTUAL

#### Start Date
**Date:** 2011-05

**Status Verified Date:** 2014-09

#### Study First Post Date
**Date:** 2011-04-13
**Type:** ESTIMATED
**Study First Submit Date:** 2011-04-11
**Study First Submit QC Date:** 2011-04-12
### Sponsor Collaborators Module

#### Collaborators

**Class:** INDUSTRY

**Name:** Genentech, Inc.

#### Lead Sponsor

**Class:** OTHER

**Name:** The New York Eye Cancer Center

#### Responsible Party

**Investigator Affiliation:** The New York Eye Cancer Center

**Investigator Full Name:** Paul T. Finger, MD

**Investigator Title:** Principal Investigator

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Oversight Has DMC:** True

### Description Module

**Brief Summary:** This study investigates the use of a high dose anti-VEGF agent for the treatment of radiation retinopathy in those patients who have recalcitrant disease.

**Detailed Description:** This study is an open-label, Phase I study of intravitreally administered ranibizumab in subjects with radiation retinopathy. This is a single center, non-randomized, active treatment study involving 10 consecutive patients. This study will evaluate the safety and tolerability of a high dose (2.0 mg) intravitreal ranibizumab and its effect on regression of radiation retinopathy and mean change in visual acuity.

### Conditions Module

**Conditions:**

- Radiation Retinopathy

**Keywords:**

- radiation

- retinopathy

- anti-VEGF

- eye

### Design Module

#### Design Info

**Allocation:** NON_RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 10

**Type:** ACTUAL

**Phases:**

- PHASE1

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** 5 patients will receive intravitreal injections every 30 days (+/- 7 days) for the first 4 months and every month thereafter until month 12 (maximum of 12 injections)

**Intervention Names:**

- Drug: ranibizumab 2.0 mg

**Label:** With Loading Doses

**Type:** ACTIVE_COMPARATOR

#### Arm Group 2

**Description:** 5 patients will receive intravitreal ranibizumab every 30 days (+/- 7 days) on as needed basis based on the criteria defined in the study.

**Intervention Names:**

- Drug: ranibizumab 2.0 mg

**Label:** Physician Discretion

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Physician Discretion

- With Loading Doses

**Description:** Intravitreal ranibizumab (2.0 mg)

**Name:** ranibizumab 2.0 mg

**Other Names:**

- Lucentis

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Description:** All subjects will be assessed at baseline, at 7 days after first injection, and monthly for adverse events. The primary outcome measures for safety and tolerability are: 1. incidence and severity of ocular adverse events, as identified by eye examination (including best corrected visual acuity testing) and 2. Incidence and severity of other adverse events, as identified by physical examination, subject reporting, and changes in vital signs

**Measure:** Number of participants with adverse events (allergy, infection, or change in vital signs)

**Time Frame:** Baseline, at day 7, then monthly

#### Secondary Outcomes

**Description:** This secondary outcome measure will evaluate the effect of ranibizumab in both groups (arms) on Regression of radiation retinopathy as measured by mean change in central retinal thickness as measured on optical coherence tomography (OCT) compared to baseline

**Measure:** Number of participants with changes in central foveal thickness

**Time Frame:** Monthly, Report at Month 12

**Description:** Each month each subject will be tested for best corrected visual acuity as compared to baseline.

**Measure:** Number of participants with changes in visual acuity

**Time Frame:** Monthly, Report at Month 12

**Description:** Each group (arm) will be assessed for the number of monthyl injections received through Month 12.

**Measure:** Number of injections each group (arm) has received

**Time Frame:** Monthly, Report at Month 12

**Description:** Evaluation of both arms on qualitative change in exudates, retinal hemorrhage, microaneurym and neovascularization) as seen on ophthalmoscopy/color photography and fluorescein angiography compared to baseline.

**Measure:** Number of participants with qualitative changes in retinopathy on ophthalmoscopy and fluorescein angiography

**Time Frame:** Monthly Report at Month 12

### 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 \> 21 years
* History of a clinical diagnosis of radiation retinopathy
* Subjects who are at least 3 months and no more than 10 years from radiation therapy
* History of prior treatment for radiation retinopathy with incomplete response (eg. persistent edema, presence of hemorrhage, presence of exudates, etc
* ETDRS best corrected visual acuity of 20/400 or better in the study eye
* Ability to return for all study visits

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
* Subject with significantly compromised visual acuity in the study eye due to concomitant ocular conditions.
* Subjects who have undergone intraocular surgery within last 60 days.
* Subjects who have had intravitreal anti-VEGF treatment within 30 days.
* Subjects who have had intravitreal triamcinolone acetonide within 4 months.
* Subjects who have had laser within 60 days.
* Inability to obtain photographs to document CNV (including difficulty with venous access).
* Subject with known adverse reaction to fluorescein dye.
* Subject has a history of any medical condition which would preclude scheduled visits or completion of study.
* Aphakia or absence of the posterior capsule in the study eye. Previous violation of the posterior capsule in the study eye is also excluded unless as a result of yttrium aluminum garnet (YAG) posterior capsulotomy in association with posterior chamber lens implantation..
* History of glaucoma filtering surgery in the study eye.
* Concurrent use of more than two therapies for glaucoma.
* Uncontrolled glaucoma in the study eye (defined as intraocular pressure \>30 mm Hg despite treatment with anti-glaucoma medication)
* Inability to comply with study or follow-up procedure

**Minimum Age:** 21 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** New York

**Country:** United States

**Facility:** The New York Eye Cancer Center

**State:** New York

**Zip:** 10065

#### Overall Officials

**Official 1:**

**Affiliation:** The New York Eye Cancer Center

**Name:** Paul T Finger, MD

**Role:** PRINCIPAL_INVESTIGATOR

### References Module

#### See Also Links

**Label:** Dr. Finger's Radiation Retinopathy Studies

**URL:** http://www.ncbi.nlm.nih.gov/pubmed?term=radiation%20retinopathy%20Finger%20PT

## Derived Section

### Condition Browse Module - Ancestors

- 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: M14999

- Name: Retinal Diseases

- Relevance: HIGH

- As Found: Retinopathy

- ID: M8271

- Name: Eye Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000012164

- Term: Retinal Diseases

### 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
