Clinical Trial: Intravitreal Ranibizumab (Lucentis®) for Neovascular Glaucoma- a Randomized Controlled Study

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

Official Title: Intravitreal Ranibizumab (Lucentis®) for Neovascular Glaucoma- a Randomized Controlled Study

Brief Summary: Neovascular glaucoma is a potentially blinding condition characterized by the growth of newvessels at the anterior part of the eye. This growth is driven by the overexpression of a protein called Vascular Endothelial Growth Factor (VEGF). That happens in diseases such as diabetic retinopathy or venous retinal occlusion, and lead to a fast increase in intraocular pressure (IOP). Traditional treatment include laser photocoagulation of the retina in order to decrease VEGF formation. The investigators postulate that the use of anti-VEGF intravitreal injections may accelerate recovery and decrease the need of surgery in cases of neovascular glaucoma.

Detailed Summary:

This is a prospective, randomized controlled study that aims to evaluate the efficacy of ranibizumab (Lucentis®) as an adjunct in the treatment of patients with neovascular glaucoma.

28 patients with neovascular glaucoma (14 in the study group and 14 in the control standard of care group) will be recruited at a single center- University of Sao Paulo Medical School General Hospital. A complete ophthalmologic exam will be carried out, including the obtention of an informed consent for eligible patients willing to participate on the study.

Patients will be randomly assigned to either standard of care- retinal laser photocoagulation and clinical management of intraocular pressure with drops, or standard of care plus intravitreal ranibizumab injections. Two injections will be performed 30 days apart. The patients will be followed for 6 months.


Sponsor: LEANDRO CABRAL ZACHARIAS

Current Primary Outcome: Intraocular pressure [ Time Frame: 6 months ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Anterior segment neovascularization [ Time Frame: 6 months ]
  • Best corrected visual acuity [ Time Frame: 6 months ]
  • Number of drugs needed for IOP control [ Time Frame: 6 months ]
  • Need for IOP control surgery [ Time Frame: 6 months ]


Original Secondary Outcome:

  • Iris neovascularization [ Time Frame: 6 months ]
  • Best corrected visual acuity [ Time Frame: 6 months ]
  • Number of topical IOP control drops [ Time Frame: 6 months ]
  • Need for IOP control surgery [ Time Frame: 6 months ]


Information By: University of Sao Paulo General Hospital

Dates:
Date Received: September 22, 2016
Date Started: October 2016
Date Completion: October 2018
Last Updated: September 24, 2016
Last Verified: September 2016