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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2012 by Pacific Eye Associates.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Genentech
Information provided by (Responsible Party):
Anne Fung MD, Pacific Eye Associates
ClinicalTrials.gov Identifier:
NCT01189019
First received: August 24, 2010
Last updated: April 10, 2012
Last verified: April 2012
  Purpose

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 Intervention Phase
Wet Macular Degeneration
Macular Degeneration
Pigment Epithelium of Eye
Retinal Detachment
Drug: ranibizumab
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: High Dose Lucentis for Persistent Pigment Epithelial Detachment in Neovascular Age-related Macular Degeneration - The HiPED Study

Resource links provided by NLM:


Further study details as provided by Pacific Eye Associates:

Primary Outcome Measures:
  • Mean change in visual acuity from baseline to 24 months [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    Best corrected visual acuity on the ETDRS chart at 4 meters will be compared


Secondary Outcome Measures:
  • Visual acuity from baseline to 6 months [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    BCVA on ETDRS will be compared from baseline to 6 months

  • Safety [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    incidence and severity of ocular and non-ocular adverse events will be evaluated through 12 months

  • % with > 15 ETDRS letter gain from baseline through 12 months [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Change in OCT CST from baseline through 6 and 12 months [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Time to recurrence of PED in PRN Arm [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: August 2010
Estimated Study Completion Date: March 2013
Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01189019

Locations
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
Investigators
Principal Investigator: Anne Fung, MD Pacific Eye Associates / California Pacific Medical Center
  More Information

Additional Information:
No publications provided

Responsible Party: Anne Fung MD, Principal Investigator, Pacific Eye Associates
ClinicalTrials.gov Identifier: NCT01189019     History of Changes
Other Study ID Numbers: FVF4928
Study First Received: August 24, 2010
Last Updated: April 10, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Pacific Eye Associates:
ranibizumab
Pigment Epithelium of Eye
retinal detachment
Wet macular degeneration
macular degeneration

Additional relevant MeSH terms:
Macular Degeneration
Dissociative Disorders
Retinal Detachment
Wet Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Mental Disorders

ClinicalTrials.gov processed this record on September 22, 2014