Recruiting

Ozurdex vs. Ranibizumab

Sponsor:

Valley Retina Institute

Code:

NCT01827722

Conditions

Macular Edema

Central Retinal Vein Occlusion

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Ozurdex

Ranibizumab

Combination Ozurdex with Ranibizumab PRN

Study Details

Brief summary:

CRVO occurs when the vessels in the back of the eye become blocked. This creates a dangerous condition because the vessels are weak and prone to leakage. This results in the development of macular edema.

Previous studies have shown that inflammatory mediators and growth factors, such as vascular endothelial growth factor (VEGF), are elevated in patients with macular edema associated with CRVO.

Ozurdex® is approved by the Food and Drug Administration (FDA) and is available by prescription for macular edema following CRVO and branch retinal vein occlusion (BRVO). It is also indicated for the treatment of non-infectious uveitis affecting the posterior segment of the eye. The approved dosage is 0.7 mg.

Ranibizumab (Lucentis®) is approved by the Food and Drug Administration (FDA) and is available by prescription for other eye disorders, such as wet age-related macular degeneration (AMD), macular edema following CRVO or BRVO, and diabetic macular edema (DME). The approved dosage for wet AMD and macular edema following CRVO/BROV is 0.5 mg given monthly. The approved dosage for DME is 0.3 mg given monthly.

Dr. Gonzalez is conducting an investigational study on the safety and effectiveness of treating CRVO-associated Macular Edema with a combination of 0.7 mg of Ozurdex® and 0.5 mg Lucentis®, given as separate injections into the eye.

Conditions

Macular Edema

Central Retinal Vein Occlusion

Study ID

NCT01827722

Start date

May, 2013

Status verified date

Dec, 2015

Completion date

Dec, 2016

Anticipated

Primary completion date

May, 2016

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Adults greater than or equal to 18 years of age with foveal center involved macular edema secondary to CRVO diagnosed within 12 months before the screening visit (CRVO is defined as an eye with retinal hemorrhage or other biomicroscopic evidence of RVO \[eg telangiectatic capillary bed\] and a dilated \[or previously dilated\] venous system in at least 3 quadrants of the retina drained by the affected vein.
  • Best corrected visual acuity (ETDRS) letter score of 73 to 24 inclusive (20/40 to 20/320) in the study eye at Screening and at Day 1
  • Mean central subfield thickness greater than or equal to 310 µm from 2 OCT measurements (Spectralis HRA + OCT) at Screening and Day 1
  • Willing and able to comply with clinic visits and study-related procedures
  • Ability to provide signed informed consent form

Exclusion Criteria:

  • History of vitreoretinal surgery in the study eye or anticipated within 12 months of Day 1
  • Current bilateral manifestation of CRVO
  • Decrease in VA due to causes other than CRVO in the study eye
  • Prior episode of RVO in study eye
  • Afferent pupillary defect, obvious and unequivocal
  • Greater than 10 letter improvement in BCVA between Screening and Day 1
  • History or presence of exudative or dry macular degeneration
  • Panretinal scatter photocoagulation or sector laser photocoagulation within 3 months prior to Day 1 or anticipated within 4 months after Day 1
  • Anticipated laser photocoagulation for macular edema within 4 months after Day 1
  • History of or evidence on examination of any diabetic retinopathy in the study eye
  • CVA or MI within 3 months prior to Day 1
  • Prior anti-VEGF treatment in study or fellow eye within 3 months before day 1 or systemic anti-VEGF or pro-VEGF treatment within 6 months prior to Day 1
  • Ocular or periocular infections including active or suspected viral diseases of the cornea and conjunctiva, active epithelial herpes simples keratitis (dendritic keratitis), vaccinia, varicella, mycobacterial infections, and fungal diseases
  • Glaucoma or current ocular hypertension requiring more than 1 medication to control IOP in the study eye or a history of steroid induced IOP increase in either eye
  • Prior Ozurdex treatment in study eye within 4 months prior to Day 1
  • Aphakic eyes with rupture of posterior lens capsule
  • Anterior chamber IOL and rupture of posterior lens capsule
  • Hypersensitivity to any components of Ozurdex or Ranibizumab in either eye
  • History of other disease, metabolic dysfunction, physical exam finding, including renal failure on dialysis which renders the patient at high risk from treatment complications based on the judgment of the Investigator's at his/her discretion.
  • Sexually active men or women of childbearing potential who are unwilling to practice adequate contraception during the study (adequate contraceptive measures include stable use of oral contraceptives or other prescription pharmaceutical contraceptives for 2 or more menstrual cycles prior to screening; intrauterine device; bilateral tubal ligation; vasectomy; condom plus contraceptive sponge, foam, or jelly, or diaphragm plus contraceptive sponge, foam, or jelly).

Study Design

Enrollment

45 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Ozurdex Arm

Ozurdex intravitreal injection (combination with monthly sham injection) administered at a 16 week interval beginning on Day 1 and ending at Week 16.

experimental: Ranibizumab Arm

Ranibizumab injection (combination with sham injections beginning on Day 1 and Week 16) administered at monthly intervals beginning Day 1 and ending at Week 20.

experimental: Combination Ozurdex with Ranibizumab PRN

Ozurdex intravitreal injection administered at 16 week intervals beginning on Day 1 and ending at Week 16 with an initial IV Ranibizumab injection administered at Day 1, then treated with Ranibizumab according to reinjection parameters assessed monthly (in combination with sham if reinjection parameters are not met).

Reinjection Parameters:

10 letter drop from best corrected visual acuity or a 100 µm increase in central retinal thickness according to optical coherence tomography (Spectralis HRA + OCT).

Interventions

Ozurdex

Intravitreal injection of Ozurdex

Ranibizumab

Intravitreal Injection of Ranibizumab

Combination Ozurdex with Ranibizumab PRN

Intravitreal Injection of combination medication Ozurdex and Ranibizumab

Primary outcome measure

  • Best Corrected Visual Acuity [ Time Frame: 24 weeks ]

Central Contacts and Locations

Central contacts

VICTOR H GONZALEZ, MD

956-631-8875RESEARCH@VRITX.COM

YESENIA SALINAS, MA

956-631-8875YSALINAS@VRITX.COM

Locations

Retina Vitreous Associates Medical Group

Recruiting

Beverly Hills, California, United States, 90211

Contacts

Daniel Bandary

310-289-2478Dbandary@laretina.com

Janet Kurokouchi

310-289-2478

Principal Investigator:

David S Boyer, MD

Retina Associates

Recruiting

Lakeland, Florida, United States, 33805

Contacts

Lexie Manning

913-831-7400lmanning@kcretina.com

Principal Investigator:

David Boyer, MD

Center for Retina and Macular Disease

Recruiting

Winter Haven, Florida, United States, 33880

Contacts

Dawn Sutherland

863-297-5400dasu@crmd.net

Vera Dilts

863-297-5400vedi@crmd.net

Principal Investigator:

Michael Tolentino, MD

Valley Retina Institute, PA

Recruiting

Harlingen, Texas, United States, 78552

Contacts

Anegelina Garza, BS

956-423-2100a_garza@vritx.com

Lissete Villanueva, MA

956-423-2100lvillarreal@vritx.com

Principal Investigator:

Victor H. Gonzalez, MD

Valley Retina Institute, PA

Recruiting

McAllen, Texas, United States, 78503

Contacts

Yesenia Salinas, MA

956-631-8875ysalinas@vritx.com

Amber Ibarra, BS

956-631-8875aibarra@vritx.com

Principal Investigator:

Victor H Gonzalez, MD

More Information

Sponsor

Valley Retina Institute

Last update posted

Dec 14, 2015

Last verified

Dec, 2015

Keywords

  • Macular edema
  • Central retinal vein occlusion
  • CRVO
  • Retinal vein occlusion
  • RVO
  • Ozurdex
  • Dexamethasone intravitreal implant
  • Lucentis
  • Ranibizumab

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Valley Retina Institute on 2015-12-14.