Recruiting
Phase 2

Observational Study

Sponsor:

California Retina Consultants

Code:

NCT02067013

Conditions

Proliferative Diabetic Retinopathy

Macular Degeneration

Macular Hole

Neovascular Glaucoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Ranibizumab

No Ranibizumab

Study Details

Brief summary:

Clinical Retina research studies often collect aqueous samples in hopes of estimating levels of drug or cytokines in the vitreous. Little is known about how well vitreous and aqueous correlate. This study will collect vitreous and aqueous samples at the same time to evaluate and compare drug and cytokine levels.

The overall objective of this study is to evaluate the molecular concentration of growth factors, cytokines and chemokines in human aqueous humor and vitreous samples collected from individuals undergoing pars plana vitrectomy for tractional retinal detachment secondary to proliferative diabetic retinopathy, exudative or tractional retinal detachment secondary to macular degeneration, macular hole or neovascular glaucoma.

Conditions

Proliferative Diabetic Retinopathy

Macular Degeneration

Macular Hole

Neovascular Glaucoma

Study ID

NCT02067013

Start date

Jul, 2015

Status verified date

Feb, 2017

Completion date

Jul, 2017

Anticipated

Primary completion date

Jul, 2017

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Ability to provide written informed consent and comply with study assessments for the full duration of the study
  • Age > 18 years
  • Subjects with a diagnosis of tractional retinal detachment secondary to proliferative diabetic retinopathy, age-related macular degeneration with tractional or exudative retinal detachment, macular hole, epiretinal membrane, or neovascular glaucoma.

Exclusion Criteria:

  • Subjects with history of vitrectomy in the study eye
  • Presence of vitreous hemorrhage
  • Subjects with history of laser photocoagulation in the study eye within 3 months of vitrectomy
  • Subjects unwilling to undergo pars plana vitrectomy
  • Subjects unwilling to receive intravitreal ranibizumab prior to pars plana vitrectomy unless diagnosis of macular hole or epiretinal membrane
  • Subjects who may need or have received systemic anti-VEGF for oncology in the past year
  • Subjects with history of anti-VEGF injection within 4 months before vitrectomy

Study Design

Enrollment

45 participants

Anticipated

Allocation

Non randomized

Intervention Model

Single group

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

active comparator: Ranibizumab

Subjects undergoing surgery for neovascular glaucoma, diabetic retinopathy, or tractional Retinal Detachment due to AMD will receive one intravitreal injection of ranibizumab within 2 weeks of their surgery. Vitreous and aqueous humor samples will be collected during the surgery. Serum samples may be collected before, during, or after surgery.

placebo comparator: Control

Subjects undergoing surgery for ERM or macular hole will NOT receive an injection of ranibizumab, but will have vitreous, and aqueous humor samples collected during surgery (no serum collection).

Interventions

Ranibizumab

Subjects in the Ranibizumab arm will receive an injection of drug within 2 weeks prior to their surgery.

No Ranibizumab

Subjects in the control arm will NOT receive an injection of drug within 2 weeks prior to their surgery.

Primary outcome measure

  • Cytokine Levels [ Time Frame: Collected at Baseline ]

Central Contacts and Locations

Central contacts

Gabriel Gordon, PhD

805-963-1648gabe@californiaretina.com

Locations

California Retina Consultants - Santa Barbara Office

Recruiting

Santa Barbara, California, United States, 93103

Contacts

Gabriel Gordon, PhD

805-963-1648gabe@californiaretina.com

Principal Investigator:

Robert L Avery, MD

More Information

Sponsor

California Retina Consultants

Last update posted

Mar 1, 2017

Last verified

Feb, 2017

Keywords

  • Tractional retinal detachment
  • Exudative retinal detachment
  • Macular hole
  • Neovascular glaucoma

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-03. This information was provided to ClinicalTrials.gov by California Retina Consultants on 2017-03-01. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.