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Trial record 4 of 35 for:    retina associates of kentucky

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01189019
Recruitment Status : Terminated (Drug dose became unavailable)
First Posted : August 26, 2010
Last Update Posted : March 29, 2016
Genentech, Inc.
Information provided by (Responsible Party):
Anne Fung MD, Pacific Eye Associates

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.

Condition or disease Intervention/treatment Phase
Wet Macular Degeneration Macular Degeneration Retinal Pigment Epithelial Detachment Drug: ranibizumab Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: High Dose Lucentis for Persistent Pigment Epithelial Detachment in Neovascular Age-related Macular Degeneration - The HiPED Study
Study Start Date : August 2010
Actual Primary Completion Date : March 2013
Actual Study Completion Date : March 2013

Arm Intervention/treatment
Experimental: Group 1 - 2mg ranibizumab monthly
2mg ranibizumab monthly
Drug: ranibizumab
2mg intravitreal injection monthly

Active Comparator: Group 2 - 2mg x 3 then PRN Drug: ranibizumab
2mg monthly x 3 doses, then as needed based on recurrence of activity on OCT

Primary Outcome Measures :
  1. Mean change in visual acuity from baseline to 24 months [ Time Frame: 24 months ]
    Best corrected visual acuity on the ETDRS chart at 4 meters will be compared

Secondary Outcome Measures :
  1. Visual acuity from baseline to 6 months [ Time Frame: 6 months ]
    BCVA on ETDRS will be compared from baseline to 6 months

  2. Safety [ Time Frame: 12 months ]
    incidence and severity of ocular and non-ocular adverse events will be evaluated through 12 months

  3. % with > 15 ETDRS letter gain from baseline through 12 months [ Time Frame: 12 months ]
  4. Change in OCT CST from baseline through 6 and 12 months [ Time Frame: 12 months ]
  5. Time to recurrence of PED in PRN Arm [ Time Frame: 12 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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


  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01189019

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United States, California
Pacific Eye Associates
San Francisco, California, United States, 94115
United States, Kentucky
Retina Associates of Kentucky
Lexington, Kentucky, United States, 40509
United States, Tennessee
Tennessee Retina
Nashville, Tennessee, United States, 37203
Sponsors and Collaborators
Anne Fung MD
Genentech, Inc.
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Principal Investigator: Anne Fung, MD Pacific Eye Associates / California Pacific Medical Center
Additional Information:
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Responsible Party: Anne Fung MD, Principal Investigator, Pacific Eye Associates Identifier: NCT01189019    
Other Study ID Numbers: FVF4928
First Posted: August 26, 2010    Key Record Dates
Last Update Posted: March 29, 2016
Last Verified: March 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Presented at medical conferences, manuscript in preparation
Keywords provided by Anne Fung MD, Pacific Eye Associates:
Wet macular degeneration
macular degeneration
Retinal Pigment Epithelial Detachment
Additional relevant MeSH terms:
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Retinal Detachment
Retinal Degeneration
Retinal Diseases
Macular Degeneration
Wet Macular Degeneration
Dissociative Disorders
Eye Diseases
Mental Disorders
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents