Prophylactic Ranibizumab for Exudative Age-Related Macular Degeneration (PROTECT)

August 27, 2018 updated by: Leonard Feiner, MD, PhD

Prospective Double-blind Randomized Study to Evaluate Lucentis for Prophylaxis Against the Conversion to Neovascular Age-related Macular Degeneration (AMD) in High-risk Eyes (Let's ProTECT AMD Eyes)

To evaluate Ranibizumab as prophylaxis against the conversion to neovascular Age-Related Macular Degeneration

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is an open-label, prospective, randomized study of intravitreally administered ranibizumab 0.5 mg in subjects with unilateral neovascular AMD in which the fellow (study) eye is at high-risk for also developing conversion to neovascular AMD.

The Study will determine the efficacy of a quarterly injection of Ranibizumab to prevent the conversion of dry age-related macular degeneration to neovascular AMD in high risk eyes.

Study Type

Interventional

Enrollment (Actual)

4

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New Jersey
      • Teaneck, New Jersey, United States, 07666
        • NJ Retina (Retina Associates of New Jersey)
      • Vauxhall, New Jersey, United States, 07088
        • NJ Retina (Retina Associates of New Jersey)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

46 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Adults over 50 years old
  • Able to sign informed consent and comply with the study protocol for the duration of the two years.
  • Nonexudative age-related macular degeneration (AMD) in one eye (study eye) •At time of enrollment, fellow non-study eye must have recently diagnosed (not more than 2 years prior to enrollment), angiographically documented, previously untreated prior to diagnosis, CNV lesion (i.e., leakage on fluorescein angiography AND subretinal, intraretinal, or sub-RPE fluid on OCT) secondary to age-related macular degeneration.

Exclusion Criteria:

  • Previous treatment with verteporfin PDT, Macugen®, Lucentis®, intravitreal Avastin®, intravitreal Eylea®, thermal laser, external beam radiation or other AMD therapy in the study eye.
  • History of macular hole in study eye.
  • History of vitrectomy in study eye.
  • Lens extraction or implantation within the last 3 months.
  • Capsulotomy within the last 1 month.
  • Lens or other media opacity that would preclude good fundus photography or angiography within the next 2 years.
  • Nevus > 2 disc areas within 3000 microns of the foveal center or with fluid or leakage on fluorescein angiography.
  • Macular edema or signs of diabetic retinopathy more severe than 10 red dots (microaneurysms or blot hemorrhages).
  • Retinal changes related to high myopia and no myopic correction greater than 8.00 diopters spherical equivalent [sphere + ½ cylinder].
  • Any progressive ocular disease that would affect visual acuity within the next 2 years.
  • Previous participation in any studies of investigational drugs likely to have ocular effects within 30 days preceding the initial study treatment.
  • Concurrent use of systemic anti-VEGF agents.
  • Active or recent (within 4 weeks) intraocular inflammation (grade trace or above) in the study eye.
  • Active infectious conjunctivitis, keratitis, scleritis, or endophthalmitis in either eye.
  • For subjects who have undergone prior refractive or cataract surgery in the study eye, the preoperative refractive error in the study eye cannot exceed 8 diopters of myopia.
  • Uncontrolled glaucoma in the study eye (defined as intraocular pressure > 25 mmHg) despite treatment with antiglaucoma medication).
  • Patients who are unable to be photographed to document CNV due to known allergy to fluorescein dye, lack of venous access or cataract obscuring the CNV.
  • Patients with other ocular diseases that can compromise the visual acuity of the study eye such as amblyopia and anterior ischemic optic neuropathy.
  • Current treatment for active systemic infection.
  • Evidence of significant uncontrolled concomitant diseases such as cardiovascular disease, nervous system, pulmonary, renal, hepatic, endocrine, or gastrointestinal disorders.
  • History of recurrent significant infections or bacterial infections.
  • Inability to comply with study or follow-up procedures.
  • Pregnancy (positive pregnancy test) or lactation Premenopausal women not using adequate contraception. The following are considered effective means of contraception: surgical sterilization or 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.
  • Any other condition that the investigator believes would pose a significant hazard to the subject if the investigational therapy were initiated
  • Participation in another simultaneous medical investigation or trial

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Observation
No treatment. Observation only
Active Comparator: Quarterly Ranibizumab 0.5
Quarterly intravitreal injection of 0.5mg Ranibizumab Intervention: Drug: Ranibizumab 0.5mg
Drug: Ranibizumab 0.5mg
Other Names:
  • Lucentis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Conversion to neovascular AMD. (CNV leakage on FA and evidence of any fluid on SD-OCT)
Time Frame: 2 years
The development of CNV will be assessed by CNV leakage on FA and evidence of any fluid on SD-OCT.
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Leonard Feiner, MD, PhD

Collaborators

NJ Retina (Retina Associates of New Jersey)

Investigators

  • Principal Investigator: Leonard Feiner, MD, MD, PhD, NJ Retina (Retina Associates of New Jersey)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2015

Primary Completion (Actual)

July 1, 2018

Study Completion (Actual)

July 1, 2018

Study Registration Dates

First Submitted

November 25, 2014

First Submitted That Met QC Criteria

November 26, 2014

First Posted (Estimate)

November 27, 2014

Study Record Updates

Last Update Posted (Actual)

August 28, 2018

Last Update Submitted That Met QC Criteria

August 27, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ML29346

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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