Prophylactic Ranibizumab for Exudative Age-Related Macular Degeneration

NCT02302989 | Completed Phase 1

• 1 other identifier: ML29346
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Age-related Macular Degeneration

Outcome Measures

Primary Outcomes (1)

• Conversion to neovascular AMD. (CNV leakage on FA and evidence of any fluid on SD-OCT)

  The development of CNV will be assessed by CNV leakage on FA and evidence of any fluid on SD-OCT.

  2 years

Study Arms (2)

Observation

NO INTERVENTION

No treatment. Observation only

Quarterly Ranibizumab 0.5

ACTIVE COMPARATOR

Quarterly intravitreal injection of 0.5mg Ranibizumab Intervention: Drug: Ranibizumab 0.5mg

Drug: Ranibizumab 0.5mg

Interventions

Ranibizumab 0.5mg DRUG

Also known as: Lucentis

Quarterly Ranibizumab 0.5

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Leonard Feiner, MD, PhD: lead
• NJ Retina (Retina Associates of New Jersey): collaborator

Study Sites (2)

NJ Retina (Retina Associates of New Jersey)

Teaneck, New Jersey, 07666, United States

Location

NJ Retina (Retina Associates of New Jersey)

Vauxhall, New Jersey, 07088, United States

Location

MeSH Terms

Conditions

Macular Degeneration

Interventions

Ranibizumab

Condition Hierarchy (Ancestors)

Retinal Degeneration; Retinal Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Leonard Feiner, MD, MD, PhD

  NJ Retina (Retina Associates of New Jersey)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 25, 2014
• First Posted: November 27, 2014
• Study Start: May 1, 2015
• Primary Completion: July 1, 2018
• Study Completion: July 1, 2018
• Last Updated: August 28, 2018

Record last verified: 2018-08

Locations

US (2)