HiPED - High Dose Lucentis for Persistent Pigment Epithelial Detachments in Age-related Macular Degeneration

NCT ID: NCT01189019

Last Updated: 2016-03-29

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-08-31
• Study Completion Date: 2013-03-31

Brief Summary

In this fifth year of anti-VEGF therapy for neovascular AMD, retinal physicians are collecting groups of patients who either do not or only partially respond to anti-VEGF therapy. This study will evaluate the efficacy and safety of 2mg ranibizumab specifically for patients with fibrovascular PEDs that have not resolved following at least 6 consecutive injections of ranibizumab or bevacizumab over the previous 12 months. The investigators hypothesize that the 2mg dose will be able to completely eliminate the persistent PEDS in these patients.

Conditions

Wet Macular Degeneration; Macular Degeneration; Retinal Pigment Epithelial Detachment

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Group 1 - 2mg ranibizumab monthly

2mg ranibizumab monthly

Group Type: EXPERIMENTAL

ranibizumab

Intervention Type: DRUG

2mg intravitreal injection monthly

Group 2 - 2mg x 3 then PRN

Group Type: ACTIVE_COMPARATOR

ranibizumab

Intervention Type: DRUG

2mg monthly x 3 doses, then as needed based on recurrence of activity on OCT

Interventions

ranibizumab

2mg intravitreal injection monthly

Intervention Type: DRUG

ranibizumab

2mg monthly x 3 doses, then as needed based on recurrence of activity on OCT

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Ability to provide written informed consent and comply with study assessments for the full duration of the study
• Age > 50 years
• Active or recurrent neovascular age-related macular degeneration involving the fovea on FA
• Presence of persistent fibrovascular pigment epithelial detachment on OCT following a minimum 6 previous treatments in previous 12 months with ranibizumab and/or bevacizumab. Patients may have received more than 12 months of anti-VEGF therapy.
• ETDRS Best Corrected Visual acuity 20/32 - 20/400

Exclusion Criteria

• Prior treatment with verteporfin, or external-beam radiation therapy, or transpupillary thermotherapy, Previous subfoveal focal laser photocoagulation involving the foveal center, History of vitrectomy, submacular surgery, or other surgical intervention for AMD, Previous participation in any studies of investigational drugs within 1 month preceding Day 0 (excluding vitamins and minerals) in study eye.
• Lesion Characteristics: Subfoveal fibrosis or atrophy in study eye, CNV in either eye due to other causes, such as ocular histoplasmosis, trauma, or pathologic myopia.
• Concurrent Ocular Conditions: Concurrent eye disease in the study eye that could compromise visual acuity (e.g., diabetic retinopathy, advanced glaucoma), Any concurrent intraocular condition in the study eye (e.g., diabetic retinopathy or glaucoma) that, in the opinion of the investigator, could either, Require medical or surgical intervention during the 12-month study period to prevent or treat visual loss that might result from that condition, or If allowed to progress untreated, could likely contribute to loss of at least 2 Snellen equivalent lines of best corrected visual acuity over the 12-month study period, Active intraocular inflammation (grade trace or above) in the study eye, or history of idiopathic or autoimmune-associated uveitis in either eye
• Current vitreous hemorrhage in the study eye
• History of rhegmatogenous retinal detachment or macular hole (Stage 3 or 4) in the study eye
• Infectious conjunctivitis, keratitis, scleritis, or endophthalmitis in either eye
• Aphakia or absence of the posterior capsule in the study eye unless it occurred as a result of YAG posterior capsulotomy in association with prior, posterior chamber intraocular lens implantation.
• Uncontrolled glaucoma in the study eye (defined as intraocular pressure 30 mmHg despite treatment with anti-glaucoma medication)

Concurrent Systemic Conditions

• Pregnancy or premenopausal women not using adequate contraception The following are considered effective means of contraception: surgical sterilization; 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.
• History of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use an investigational drug or that might affect interpretation of the results of the study or render the subject at high risk for treatment complications

Other

• Inability to dilate pupils sufficient for adequate fluorescein angiography
• Inability to comply with study or follow up procedures

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

• Pregnancy (positive pregnancy test)
• Any other condition that the investigator believes would pose a significant hazard to the subject if the investigational therapy were initiated

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Genentech, Inc.

INDUSTRY

Sponsor Role: collaborator

Anne Fung MD

OTHER

Sponsor Role: lead

Responsible Party

Anne Fung MD

Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Anne Fung, MD

Role: PRINCIPAL_INVESTIGATOR

Pacific Eye Associates / California Pacific Medical Center

Locations

Pacific Eye Associates

San Francisco, California, United States

Retina Associates of Kentucky

Lexington, Kentucky, United States

Tennessee Retina

Nashville, Tennessee, United States

Countries

United States

Related Links

http://www.pacificeye.com

Pacific Eye Associates

http://www.retinaky.com/

Retina Associates of Kentucky

Other Identifiers

FVF4928

Identifier Type: -

Identifier Source: org_study_id