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Wet Macular DegenerationPhase 2HiPEDNCT01189019

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

A Phase 2 study testing ranibizumab in people with Wet Macular Degeneration and Macular Degeneration, run by Anne Fung MD at 3 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 50 to 99 years
What is being tested?
ranibizumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
3 sitesUnited States
Study dates
Aug 2010to Mar 2013
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 to 99 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 17Show fewer
  • 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

Trial locations and contacts

3 sites in 1 country.

United States3 sites

  • Retina Associates of Kentucky

    Lexington, Kentucky, 40509

  • Tennessee Retina

    Nashville, Tennessee, 37203

  • Pacific Eye Associates

    San Francisco, California, 94115

Other trials in United States

About this study

Official title: High Dose Lucentis for Persistent Pigment Epithelial Detachment in Neovascular Age-related Macular Degeneration - The HiPED Study

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.

Being tested
ranibizumab
Keywords
ranibizumab, Wet macular degeneration, macular degeneration, PED, Retinal Pigment Epithelial Detachment
Medical subject headings
Wet Macular Degeneration, Macular Degeneration, Retinal Detachment

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ranibizumabDrug

    2mg intravitreal injection monthly

  • ranibizumabDrug

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

Study groups in NCT01189019
Study groupRoleWhat they receive
Group 1 - 2mg ranibizumab monthlyExperimental2mg ranibizumab monthly
Receives: Drug: ranibizumab
Group 2 - 2mg x 3 then PRNActive comparatorNot described
Receives: Drug: ranibizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Mean change in visual acuity from baseline to 24 months

    Best corrected visual acuity on the ETDRS chart at 4 meters will be compared

    Measured: 24 months

Secondary outcomes (5)

  1. Visual acuity from baseline to 6 months

    BCVA on ETDRS will be compared from baseline to 6 months

    Measured: 6 months

  2. Safety

    incidence and severity of ocular and non-ocular adverse events will be evaluated through 12 months

    Measured: 12 months

  3. % with > 15 ETDRS letter gain from baseline through 12 months

    Measured: 12 months

  4. Change in OCT CST from baseline through 6 and 12 months

    Measured: 12 months

  5. Time to recurrence of PED in PRN Arm

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Aug 2010 (estimated)
  2. Study startAug 2010
  3. Primary completionMar 2013
  4. Study completionMar 2013

Why it stopped: Drug dose became unavailable

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01189019
Sponsor's protocol ID
FVF4928
Acronym
HiPED
Status last verified
Mar 2016
First submitted
24 Aug 2010
Last updated
29 Mar 2016
Results posted
No
Data monitoring committee
Yes
Individual data sharing
Yes: Presented at medical conferences, manuscript in preparation

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing ranibizumab in people with Wet Macular Degeneration and Macular Degeneration, run by Anne Fung MD at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 29 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Drug dose became unavailable). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean change in visual acuity from baseline to 24 months (time frame: 24 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01189019.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2016.

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