Retinal Vein Occlusion
Conditions
Brief summary
To measure the pro-permeability factors in the aqueous humor of patients with persistent/recurrent macular edema after an injection of Ozurdex.
Detailed description
To measure various pro-permeability factors in the aqueous humor of patients with persistent/recurrent macular edema despite prior treatment with anti-VEGF agents at baseline and at 4 weeks after intraocular injection of OZURDEX.
Interventions
Sponsors
Allergan
Johns Hopkins University
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Signed informed consent and authorization of use and disclosure of protected health information * Age more than or equal to 18 years * Diagnosis of macular edema due to central or branch retinal vein occlusion * Intraretinal or subretinal fluid in the macula determined by Spectralis OCT * Best corrected visual acuity score in the study eye of 20/30 to 20/400 inclusive (Snellen equivalents using the ETDRS protocol at a distance of 4 meters) * In the opinion of the investigator, decreased vision in the study eye is due to foveal thickening from vein occlusion and not from other obvious causes of decreased vision * Persistent or recurrent edema despite prolonged treatment with an anti-VEFG agent
Exclusion criteria
* Scatter laser photocoagulation or macular photocoagulation within 3 months of study entry in the study eye * Intraocular surgery in the study eye within 3 months of study entry * Use of intraocular or periocular injection of steroids in the study eye (e.g., triamcinolone) within 4 months of study entry * Previous use of an anti-VEGF drug within 1 month of study entry * Yttrium-Aluminum-Garnet (YAG) laser capsulotomy within 1 month of study entry * Any condition that the investigator believes would pose a significant hazard to the subject if investigational therapy were initiated. * Inability to comply with study or follow up procedures * History of glaucoma or documented history of steroid-induced glaucoma. * Patients with active or suspected ocular or periocular infection, including most viral diseases of the cornea and conjunctiva, including active epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, varicella, mycobacterial infections, and fungal diseases. * Aphakic eyes with rupture of the posterior lens capsule. * Eyes with ACIOL and rupture of the posterior lens capsule. * Patients with hypersensitivity to dexamethasone or to any other components of the product
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Had a >30% Decrease in the Aqueous Levels of Various Vasoactive Proteins 4 Weeks After an Injection of Ozurdex | 4 months | Vasoactive protein arrays and Enzyme linked immunosorbent assays were done for patients at baseline and week 4 visit to measure the levels of various pro-permeability factors including VEGF, SDF-1 and Angiopoietin-2. |
Countries
United States
Participant flow
Recruitment details
40 patients from the clinic population of the Wilmer Eye Institute were recruited,
Participants by arm
| Arm | Count |
|---|---|
| CRVO Central Retinal Vein Occlusion
dexamethasone implant | 23 |
| BRVO Branch Retinal Vein Occlusion
dexamethasone implant | 17 |
| Total | 40 |
Baseline characteristics
| Characteristic | CRVO | BRVO | Total |
|---|---|---|---|
| Age, Continuous | 74 years | 72 years | 73 years |
| Sex: Female, Male Female | 11 Participants | 5 Participants | 16 Participants |
| Sex: Female, Male Male | 12 Participants | 12 Participants | 24 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 8 / 23 | 5 / 17 |
| serious Total, serious adverse events | 1 / 23 | 2 / 17 |
Outcome results
Primary
Number of Participants Who Had a >30% Decrease in the Aqueous Levels of Various Vasoactive Proteins 4 Weeks After an Injection of Ozurdex
Vasoactive protein arrays and Enzyme linked immunosorbent assays were done for patients at baseline and week 4 visit to measure the levels of various pro-permeability factors including VEGF, SDF-1 and Angiopoietin-2.
Time frame: 4 months
Population: All enrolled (23 CRVO and 17 BRVO) patients completed the study. All patients were injected with Ozurdex, however microarrays were run on only 11 CRVO and 17 BRVO patient samples. Microarray data from 11 CRVO and 11 BRVO patients was analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CRVO | Number of Participants Who Had a >30% Decrease in the Aqueous Levels of Various Vasoactive Proteins 4 Weeks After an Injection of Ozurdex | Endostatin | 7 participants |
| CRVO | Number of Participants Who Had a >30% Decrease in the Aqueous Levels of Various Vasoactive Proteins 4 Weeks After an Injection of Ozurdex | HGF | 7 participants |
| CRVO | Number of Participants Who Had a >30% Decrease in the Aqueous Levels of Various Vasoactive Proteins 4 Weeks After an Injection of Ozurdex | EG-VEGF | 7 participants |
| CRVO | Number of Participants Who Had a >30% Decrease in the Aqueous Levels of Various Vasoactive Proteins 4 Weeks After an Injection of Ozurdex | Activin-A | 4 participants |
| CRVO | Number of Participants Who Had a >30% Decrease in the Aqueous Levels of Various Vasoactive Proteins 4 Weeks After an Injection of Ozurdex | IGFBP-1 | 7 participants |
| CRVO | Number of Participants Who Had a >30% Decrease in the Aqueous Levels of Various Vasoactive Proteins 4 Weeks After an Injection of Ozurdex | IGFBP-2 | 7 participants |
| CRVO | Number of Participants Who Had a >30% Decrease in the Aqueous Levels of Various Vasoactive Proteins 4 Weeks After an Injection of Ozurdex | IGF-BP3 | 7 participants |
| BRVO | Number of Participants Who Had a >30% Decrease in the Aqueous Levels of Various Vasoactive Proteins 4 Weeks After an Injection of Ozurdex | Endostatin | 6 participants |
| BRVO | Number of Participants Who Had a >30% Decrease in the Aqueous Levels of Various Vasoactive Proteins 4 Weeks After an Injection of Ozurdex | IGFBP-1 | 4 participants |
| BRVO | Number of Participants Who Had a >30% Decrease in the Aqueous Levels of Various Vasoactive Proteins 4 Weeks After an Injection of Ozurdex | HGF | 5 participants |
| BRVO | Number of Participants Who Had a >30% Decrease in the Aqueous Levels of Various Vasoactive Proteins 4 Weeks After an Injection of Ozurdex | IGF-BP3 | 6 participants |
| BRVO | Number of Participants Who Had a >30% Decrease in the Aqueous Levels of Various Vasoactive Proteins 4 Weeks After an Injection of Ozurdex | EG-VEGF | 4 participants |
| BRVO | Number of Participants Who Had a >30% Decrease in the Aqueous Levels of Various Vasoactive Proteins 4 Weeks After an Injection of Ozurdex | IGFBP-2 | 6 participants |
| BRVO | Number of Participants Who Had a >30% Decrease in the Aqueous Levels of Various Vasoactive Proteins 4 Weeks After an Injection of Ozurdex | Activin-A | 6 participants |