Intravitreal Aflibercept or Ranibizumab for Rubeosis Iridis

Instituto de Olhos de Goiania

Status and phase

Completed

Phase 3

Conditions

Rubeosis Iridis

Glaucoma

Treatments

Drug: Aflibercept

Drug: Ranibizumab

Study type

Interventional

Funder types

Other

Identifiers

NCT02641457

JN-015-2015

Details and patient eligibility

About

Aflibercept (Eylea®) and ranibizumab (Lucentis®) are an anti-VEGF, but there are differences between the two drugs. To determine and compare whether intraocular aflibercept and ranibizumab decreases rubeosis iridis (RI) in patients with neovascular glaucoma (NVG).

Full description

Aflibercept (Eylea®) and ranibizumab (Lucentis®) are an anti-VEGF, but there are differences between the two drugs. Lucentis is administered in the form of smaller molecules, which is thought to give Lucentis an advantage over Eylea in its ability to penetrate the eye's retina and halt abnormal blood vessel growth contributing to advanced macular degeneration and scarring that causes blindness. They may have a role in treating ocular disorders involving fibrovascular proliferation. To determine and compare whether intraocular aflibercept and ranibizumab decreases rubeosis iridis (RI) in patients with neovascular glaucoma (NVG).

Enrollment

2 patients

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

Criteria:

Inclusion Criteria:

Ability to provide written informed consent and comply with study assessments for the full duration of the study
Age > 18 years
Ischemic central retina vein occlusion (CRVO) within 3 months of enrollment as per the following inclusion criteria
Three of the following clinical tests must be present to demonstrate ischemic CRVO
Visual Acuity 20/200 or worse
Loss of 1-2e isopter on Goldmann Visual field (Kwon et al. 2001)
Electroretinogram demonstrating b wave amplitude less than 60% of A wave.

Exclusion Criteria:

Angle neovascularization greater than 3 clock hours with IOP over 30 (Neovascular glaucoma)
Any previous retinal laser photocoagulation to the study eye
Any previous intravitreal injection in study eye (triamcinolone or other)
Any previous vitrectomy in study eye (posterior or anterior associated with vitreous loss in cataract surgery)
Intracapsular cataract extraction (posterior capsule needs to be present)
Previous history of retinal detachment in study eye
Any previous radiation treatments to head/ neck
Inability to assess iris neovascularization (corneal opacity precluding gonioscopy)
Significant cardiovascular disease or cancer that would prevent follow-up visits or completion of the 12 month study
Significant diabetic retinopathy in the fellow eye (diabetic macular edema, proliferative diabetic retinopathy, or high-risk non-proliferative diabetic retinopathy)
Pregnancy (positive pregnancy test)
Prior enrollment in any study for vein occlusion in the study eye
Participation in another simultaneous medical investigator or trial Ocular disorders in the study eye that may confound interpretation of study results, including retinal detachment, macular hole, or choroidal neovascularization of any cause (e.g., DME AMD, ocular histoplasmosis, or pathologic myopia)
Concurrent disease in the study eye that could compromise visual acuity or require medical or surgical intervention during the study period
Aphakia or absence of the posterior capsule in the study eye
Previous violation of the posterior capsule is also excluded unless it occurred as a result of YAG laser posterior capsulotomy in association with prior, posterior chamber intraocular lens implantation
History of idiopathic or autoimmune uveitis in either eye Structural damage to the center of the macula in the study eye preexisting to CRVO likely to preclude improvement in visual acuity following the resolution of macular edema, including atrophy of the retinal pigment epithelium, subretinal fibrosis, laser scar(s)
Vitreomacular traction or epiretinal membrane in the study eye evident biomicroscopically or by OCT
Ocular inflammation (including trace or above) in the study eye Uncontrolled glaucoma (defined as intraocular pressure ≥30 mm Hg despite treatment with anti- medications) or previous filtration surgery in the study eye Systemic Conditions
Uncontrolled Blood pressure exceeding diastolic pressure of 100 mm Hg (sitting) during the screening period
Uncontrolled diabetes mellitus
Renal failure requiring dialysis or renal transplant
Premenopausal women not using adequate contraception
Previous participation in other studies of investigational drugs (excluding vitamins and minerals) within 3 months preceding Day 0
History of other disease, metabolic dysfunction, physical examination finding, or other findings giving reasonable suspicion of a disease or condition that contraindicates the use an investigational drug, might affect interpretation of the results of the study, or render the subject at high risk from treatment complications.