NCT02641457

Brief 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).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
2

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Mar 2014

Geographic Reach
1 country

1 active site

Status
completed

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

March 1, 2014

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 26, 2015

Completed
1 month until next milestone

First Posted

Study publicly available on registry

December 29, 2015

Completed
Last Updated

December 29, 2015

Status Verified

December 1, 2015

Enrollment Period

1 year

First QC Date

November 26, 2015

Last Update Submit

December 28, 2015

Conditions

GlaucomaRubeosis Iridis

Keywords

rubeosis iridisglaucomaranibizumabaflibercept

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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

Study Arms (1)

Aflibercept x Ranibizumab

EXPERIMENTAL

12 eyes received an intraocular injection of 2.00 mg of aflibercept (IA) and 12 eyes patients received an intraocular injection of 1.25mg ranibizumab

Drug: AfliberceptDrug: Ranibizumab

Interventions

AfliberceptDRUG

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.

Also known as: Eylea
Aflibercept x Ranibizumab
RanibizumabDRUG

12 eyes received an intraocular injection of 1.25mg ranibizumab and IOP were measured by tonometer. The neovascularization was evaluated by biomicroscope.

Also known as: Lucentis
Aflibercept x Ranibizumab

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
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 \> 18 years
  • 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.

You may not qualify if:

  • 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
  • +10 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Instituto de Olhos de Goiania

Goiânia, Goiás, 74110-120, Brazil

Location

MeSH Terms

Conditions

Glaucoma

Interventions

afliberceptRanibizumab

Condition Hierarchy (Ancestors)

Ocular HypertensionEye Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Joao J Nassaralla, MD PhD

    Instituto de Olhos de Goiânia

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chairman

Study Record Dates

First Submitted

November 26, 2015

First Posted

December 29, 2015

Study Start

March 1, 2014

Primary Completion

March 1, 2015

Study Completion

October 1, 2015

Last Updated

December 29, 2015

Record last verified: 2015-12

Locations

BR(1)