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

Primary Purpose

Wet Macular Degeneration, Macular Degeneration, Retinal Pigment Epithelial Detachment

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
ranibizumab
ranibizumab
Sponsored by
Anne Fung MD
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Wet Macular Degeneration focused on measuring ranibizumab, Wet macular degeneration, macular degeneration, PED, Retinal Pigment Epithelial Detachment

Eligibility Criteria

50 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Pacific Eye Associates
  • Retina Associates of Kentucky
  • Tennessee Retina

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Group 1 - 2mg ranibizumab monthly

Group 2 - 2mg x 3 then PRN

Arm Description

2mg ranibizumab monthly

Outcomes

Primary Outcome Measures

Mean change in visual acuity from baseline to 24 months
Best corrected visual acuity on the ETDRS chart at 4 meters will be compared

Secondary Outcome Measures

Visual acuity from baseline to 6 months
BCVA on ETDRS will be compared from baseline to 6 months
Safety
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
Change in OCT CST from baseline through 6 and 12 months
Time to recurrence of PED in PRN Arm

Full Information

First Posted
August 24, 2010
Last Updated
March 28, 2016
Sponsor
Anne Fung MD
Collaborators
Genentech, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01189019
Brief Title
HiPED - High Dose Lucentis for Persistent Pigment Epithelial Detachments in Age-related Macular Degeneration
Acronym
HiPED
Official Title
High Dose Lucentis for Persistent Pigment Epithelial Detachment in Neovascular Age-related Macular Degeneration - The HiPED Study
Study Type
Interventional

2. Study Status

Record Verification Date
March 2016
Overall Recruitment Status
Terminated
Why Stopped
Drug dose became unavailable
Study Start Date
August 2010 (undefined)
Primary Completion Date
March 2013 (Actual)
Study Completion Date
March 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Anne Fung MD
Collaborators
Genentech, Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Wet Macular Degeneration, Macular Degeneration, Retinal Pigment Epithelial Detachment
Keywords
ranibizumab, Wet macular degeneration, macular degeneration, PED, Retinal Pigment Epithelial Detachment

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 1 - 2mg ranibizumab monthly
Arm Type
Experimental
Arm Description
2mg ranibizumab monthly
Arm Title
Group 2 - 2mg x 3 then PRN
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
ranibizumab
Intervention Description
2mg intravitreal injection monthly
Intervention Type
Drug
Intervention Name(s)
ranibizumab
Intervention Description
2mg monthly x 3 doses, then as needed based on recurrence of activity on OCT
Primary Outcome Measure Information:
Title
Mean change in visual acuity from baseline to 24 months
Description
Best corrected visual acuity on the ETDRS chart at 4 meters will be compared
Time Frame
24 months
Secondary Outcome Measure Information:
Title
Visual acuity from baseline to 6 months
Description
BCVA on ETDRS will be compared from baseline to 6 months
Time Frame
6 months
Title
Safety
Description
incidence and severity of ocular and non-ocular adverse events will be evaluated through 12 months
Time Frame
12 months
Title
% with > 15 ETDRS letter gain from baseline through 12 months
Time Frame
12 months
Title
Change in OCT CST from baseline through 6 and 12 months
Time Frame
12 months
Title
Time to recurrence of PED in PRN Arm
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anne Fung, MD
Organizational Affiliation
Pacific Eye Associates / California Pacific Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pacific Eye Associates
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Facility Name
Retina Associates of Kentucky
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40509
Country
United States
Facility Name
Tennessee Retina
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Presented at medical conferences, manuscript in preparation
Links:
URL
http://www.pacificeye.com
Description
Pacific Eye Associates
URL
http://www.tnretina.com/tennessee/retina
Description
Tennessee Retina
URL
http://www.retinaky.com/
Description
Retina Associates of Kentucky

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

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