NCT01189019

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Aug 2010

Geographic Reach
1 country

3 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2010

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

August 24, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 26, 2010

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2013

Completed
Last Updated

March 29, 2016

Status Verified

March 1, 2016

Enrollment Period

2.6 years

First QC Date

August 24, 2010

Last Update Submit

March 28, 2016

Conditions

Wet Macular DegenerationMacular DegenerationRetinal Pigment Epithelial Detachment

Keywords

ranibizumabWet macular degenerationmacular degenerationPEDRetinal Pigment Epithelial Detachment

Outcome Measures

Primary Outcomes (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

    24 months

Secondary Outcomes (5)

  • Visual acuity from baseline to 6 months

    6 months

  • Safety

    12 months

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

    12 months

  • Change in OCT CST from baseline through 6 and 12 months

    12 months

  • Time to recurrence of PED in PRN Arm

    12 months

Study Arms (2)

Group 1 - 2mg ranibizumab monthly

EXPERIMENTAL

2mg ranibizumab monthly

Drug: ranibizumab

Group 2 - 2mg x 3 then PRN

ACTIVE COMPARATOR
Drug: ranibizumab

Interventions

ranibizumabDRUG

2mg intravitreal injection monthly

Group 1 - 2mg ranibizumab monthly

Eligibility Criteria

Age50 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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:
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Pacific Eye Associates

San Francisco, California, 94115, United States

Location

Retina Associates of Kentucky

Lexington, Kentucky, 40509, United States

Location

Tennessee Retina

Nashville, Tennessee, 37203, United States

Location

Related Links

MeSH Terms

Conditions

Wet Macular DegenerationMacular DegenerationRetinal Detachment

Interventions

Ranibizumab

Condition Hierarchy (Ancestors)

Retinal DegenerationRetinal DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • Anne Fung, MD

    Pacific Eye Associates / California Pacific Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 24, 2010

First Posted

August 26, 2010

Study Start

August 1, 2010

Primary Completion

March 1, 2013

Study Completion

March 1, 2013

Last Updated

March 29, 2016

Record last verified: 2016-03

Data Sharing

IPD Sharing
Will share

Presented at medical conferences, manuscript in preparation

Locations

US(3)