Ozurdex Versus Ranibizumab Versus Combination for Central Retinal Vein Occlusion

NCT01827722 | Unknown Phase 4

• 1 other identifier: ORION
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 5

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Best Corrected Visual Acuity

  At week 24 the mean change in best corrected visual acuity from baseline will be compared between the three groups: Ozurdex alone, Ranibizumab alone, and Ozurdex/Ranibizumab combination.

  24 weeks

Study Arms (3)

Ozurdex Arm

EXPERIMENTAL

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

Drug: Ozurdex

Ranibizumab Arm

EXPERIMENTAL

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.

Drug: Ranibizumab

Combination Ozurdex with Ranibizumab PRN

EXPERIMENTAL

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).

Drug: Combination Ozurdex with Ranibizumab PRN

Interventions

Ozurdex DRUG

Intravitreal injection of Ozurdex

Also known as: Dexamethasone

Ozurdex Arm

Ranibizumab DRUG

Intravitreal Injection of Ranibizumab

Also known as: Lucentis

Ranibizumab Arm

Combination Ozurdex with Ranibizumab PRN DRUG

Intravitreal Injection of combination medication Ozurdex and Ranibizumab

Also known as: Dexamethasone and Lucentis

Combination Ozurdex with Ranibizumab PRN

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Valley Retina Institute: lead

Study Sites (5)

Retina Vitreous Associates Medical Group

Beverly Hills, California, 90211, United States

RECRUITING

Retina Associates

Lakeland, Florida, 33805, United States

RECRUITING

Center for Retina and Macular Disease

Winter Haven, Florida, 33880, United States

RECRUITING

Valley Retina Institute, PA

Harlingen, Texas, 78552, United States

RECRUITING

Valley Retina Institute, PA

McAllen, Texas, 78503, United States

RECRUITING

MeSH Terms

Conditions

Macular Edema; Retinal Vein Occlusion

Interventions

Calcium Dobesilate; Dexamethasone; Ranibizumab

Condition Hierarchy (Ancestors)

Macular Degeneration; Retinal Degeneration; Retinal Diseases; Eye Diseases; Venous Thrombosis; Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Benzenesulfonates; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Arylsulfonates; Arylsulfonic Acids; Sulfonic Acids; Sulfur Acids; Sulfur Compounds; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• VICTOR H. GONZALEZ, MD

  VALLEY RETINA INSTITUTE, PA

  PRINCIPAL INVESTIGATOR

Central Study Contacts

VICTOR H GONZALEZ, MD

CONTACT

956-631-8875; RESEARCH@VRITX.COM

YESENIA SALINAS, MA

CONTACT

956-631-8875; YSALINAS@VRITX.COM

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 4, 2013
• First Posted: April 10, 2013
• Study Start: May 1, 2013
• Primary Completion: May 1, 2016
• Study Completion: December 1, 2016
• Last Updated: December 14, 2015

Record last verified: 2015-12

Locations

US (5)