Intravitreal Aflibercept or Ranibizumab for Rubeosis Iridis

Glaucoma Clinical Trial

Official title:

Intravitreal Aflibercept or Ranibizumab for Rubeosis Iridis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02641457
• Other study ID #: JN-015-2015
• Status: Completed
• Phase: Phase 3
• First received: November 26, 2015
• Last updated: December 28, 2015
• Start date: March 2014
• Est. completion date: October 2015

Study information

• Verified date: December 2015
• Source: Instituto de Olhos de Goiania
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Health Surveillance Agency
• Study type: Interventional

Clinical Trial Summary

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).

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2
• Est. completion date: October 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

Endpoint Classification: Bio-equivalence Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Glaucoma
• Rubeosis Iridis

Intervention

Drug:
• Aflibercept
12 eyes received an intraocular injection of 2.00 mg of aflibercept (IA) and IOP were measured by tonometer. The neovascularization was evaluated by biomicroscope.
• Ranibizumab
12 eyes received an intraocular injection of 1.25mg ranibizumab and IOP were measured by tonometer. The neovascularization was evaluated by biomicroscope.

Locations

Country	Name	City	State
Brazil	Instituto de Olhos de Goiania	Goiania	GO

Sponsors (1)

Lead Sponsor	Collaborator
Instituto de Olhos de Goiania

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Degree of rubeosis iridis by biomicroscope	Compare results of rubeosis iridis regression after aflibercept or ranibizumab intraocular injection with decrease neovascularization - 1 year follow up	1 year follow up	Yes
Primary	Degree of rubeosis iridis assessed by intraocular pressure	Compare results of rubeosis iridis regression after aflibercept or ranibizumab intraocular injection with decrease intraocular pressure (IOP) - 1 year follow up	1 year follow up	Yes