Clinically Significant Macular Edema
Conditions
Brief summary
Asses efficacy of navigated laser in reducing the number of anti-VEGF injections as a prospective study using Bevacizumab.
Detailed description
The purpose of this is study is to assess the efficacy of navigated laser treatment in reducing the number of anti-VEGF injections required to maintain visual gain obtained after Bevacizumab compared to Bevacizumab alone in patients with clinically significant macular edema (CSME). This will be prospective, active-controlled study using Bevacizumab (Genentech, South San Francisco CA) for intravitreal injections. Retinal photocoagulation will utilize the Navilas Laser System (OD-OS GmbH, Teltow, Germany), which is an approved indication for this device.
Interventions
DEVICElaser photocoagulation
Standard bevacizumab Injections will be combined with laser photocoagulation in a pre-defined manner
Sponsors
OD-OS GmbH
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
no masking
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* CSME and Diagnosis of diabetes mellitus * Able and willing to provide informed consent prior to any study-related procedures * Central foveal thickness \> 250 microns at baseline * Best corrected visual acuity between 20/400 and 20/40 * Willing and able to comply with clinic visits and study-related procedures * U.S. patients will be required to have a Health Insurance Portability and Accountability Act (HIPAA) authorization; in other countries, as applicable according to national laws
Exclusion criteria
* \- Macular edema is considered to be due to a cause other than diabetic macular edema. * An ocular condition is present such that, in the opinion of the investigator, visual acuity loss would not improve from resolution of macular edema (e.g., macular ischemia, vitreomacular traction, foveal atrophy, pigment abnormalities, dense subfoveal hard exudates, nonretinal condition). * An ocular condition is present (other than diabetes) that, in the opinion of the investigator, might affect macular edema or alter visual acuity during the course of the study (e.g., vein occlusion, uveitis or other ocular inflammatory disease, neovascular glaucoma, etc.) * Substantial cataract that, in the opinion of the investigator, is likely to be decreasing visual acuity by 3 lines or more (i.e., cataract would be reducing acuity to 20/40 or worse if eye was otherwise normal). * History of treatment for diabetic macular edema at any time in the past 4 months (such as focal/grid macular photocoagulation, intravitreal or peribulbar corticosteroids, anti-VEGF drugs, or any other treatment). * History of panretinal (scatter) photocoagulation (PRP) within 4 months prior to enrollment. * History of major ocular surgery (including vitrectomy, cataract extraction, scleral buckle, any intraocular surgery, etc.) within prior 4 months or anticipated within the next 6 months following randomization. 13 * History of YAG capsulotomy performed within 2 months prior to randomization. * Aphakia. * Intraocular pressure \>= 25 mmHg. * History of open-angle glaucoma (either primary open-angle glaucoma or other cause of open-angle glaucoma; note: history of angle-closure glaucoma is not an exclusion criterion). * History of steroid-induced intraocular pressure (IOP) elevation that required IOP-lowering treatment. * Exam evidence of external ocular infection, including conjunctivitis, chalazion, or significant blepharitis * Significant renal disease, defined as a history of chronic renal failure requiring dialysis or kidney transplant. * A condition that, in the opinion of the investigator, would preclude participation in the study (e.g., unstable medical status including blood pressure, cardiovascular disease, and glycemic control) * Participation in an investigational trial within 30 days of randomization that involved treatment with any drug that has not received regulatory approval at the time of study entry * Known allergy to any component of the study drug * Blood pressure \> 180/110 (systolic above 180 OR diastolic above 110). * Major surgery within 28 days prior to randomization or major surgery planned during the next 6 months. * Myocardial infarction, other cardiac event requiring hospitalization, stroke, transient ischemic attack, or treatment for acute congestive heart failure within 4 months prior to randomization. * Systemic anti-vascular growth factor (anti-VEGF) or pro-VEGF treatment within 4 months prior to randomization 14 * For women of child-bearing potential: pregnant or lactating or intending to become pregnant within the next 12 months. * Subject is expecting to move out of the area of the clinical center to an area not covered by another clinical center during the first 12 months of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of Eyes That Received Retreatment | 12 months |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Combination With Navigated Laser Combining photocoagulation and Anti-VEGF Injections in a pre-defined manner
Navigated laser: Standard Anti-VEGF Injections will be combined with Navigated laser in a pre-defined manner
Anti-VEGF Injections: Monotherapy | 12 |
| Monotherapy patients receive Anti-VEGF Monotherapy
Anti-VEGF Injections: Monotherapy | 0 |
| Total | 12 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 2 | 0 |
Baseline characteristics
| Characteristic | Combination With Navigated Laser | Total |
|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 6 Participants | 6 Participants |
| Age, Categorical Between 18 and 65 years | 6 Participants | 6 Participants |
| Sex: Female, Male Female | 4 Participants | 4 Participants |
| Sex: Female, Male Male | 8 Participants | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 12 | 0 / 0 |
| other Total, other adverse events | 0 / 12 | 0 / 0 |
| serious Total, serious adverse events | 0 / 12 | 0 / 0 |
Outcome results
Primary
Percentage of Eyes That Received Retreatment
Time frame: 12 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Combination With Navigated Laser | Percentage of Eyes That Received Retreatment | 55.56 Percentage of eyes that received retreat |