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LLU Eye Institute

 

RESEARCH DIVISION

 

The Loma Linda University Eye Institute would like to introduce you to our Research Division. Loma Linda has been actively

involved in many clinical trials involving diseases of the eye. The following is a brief list and description of the type of research

 projects that we are conducting. If you are interested in having your patients participate in these studies, please contact our

Research Department at (909) 558-2170 or (909) 558-2168 for more information.





 

Short-term Evaluation of Combination Corticosteroid+Anti-VEGF Treatment for

 

 Persistent Central-Involved Diabetic Macular Edema

 

Following Anti-VEGF Therapy in Pseudophakic Eyes (DRCR – Protocol U)

 

Principal Investigator: Joseph T. Fan, MD

 

Sub-Investigators: Michael E. Rauser, MD & Mukesh B. Suthar, MD

 

 

Study Objective: The main objective of this study is to assess whether the addition of steroid to an anti-VEGF treatment regimen

 in pseudophakic eyes has beneficial effect short-term in eyes with persistent DME and vision impairment despite previous

 anti-VEGF therapy, compared with continued anti-VEGF therapy alone.  Patients might be eligible to participate in this study if

 they:


•    Age >=18 years

•    Diagnosed and is currently being treated for type 1 or type 2 diabetes

•    Best corrected vision E-EDTRS is between 20/32 and 20/320

•    Has had at least 6 injections of anti-VEGF drug (ranibizumab, bevacizumab, or aflibercept) within the prior 36 weeks.

•    Pseudophakic

•    Has no history of systemic steroid, anti-VEGF or pro-VEGF treatment within 4 months prior to enrollment

or anticipated

use during the study. These drugs cannot be used during the study.


 

 

Treatment for Central-Involved Diabetic Macular Edema in Eyes With Very Good

 

 Visual Acuity (DRCR Protocol V

 

 Principal Investigator: Joseph T. Fan, MD


Sub-Investigators: Michael E. Rauser, MD & Mukesh B. Suthar, MD

 

 

Study Objective: The primary objective of the protocol is to compare the % of eyes that have lost at least 5 letters of visual

acuity at 2 years compared with baseline mean visual acuity in eyes with central-involved DME and good visual acuity defined

 as a Snellen equivalent of 20/25 or better that receive (1) prompt focal/grid photocoagulation + deferred anti-VEGF, (2)

observation + deferred anti-VEGF, or (3) prompt anti-VEGF.  Patients might be eligible to participate in this study if they meet

 the following criteria:


•    Age >=18 years

•    Diagnosed and is currently being treated for type 1 or type 2 diabetes

•    Best corrected vision E-EDTRS is 20/25 or better.

•    Diabetic macular edema confirmed on OCT (equivalent to CSF thickness on OCT ≥250 microns on Zeiss Stratus or
 gender-specific spectral domain OCT equivalent)

•    Media clarity, pupillary dilation, and individual cooperation sufficient for adequate OCT and fundus photographs.

•    Has no history of prior laser or other surgical, intravitreal, or peribulbar treatment for DME (such as focal/grid macular

photocoagulation, intravitreal or peribulbar corticosteroids, or anti-VEGF).

•    Has no history of or anticipated need for intravitreal anti-VEGF within the next 6 months for an ocular condition other than

 DME (e.g. choroidal neovascularization, central retinal vein occlusion, PDR).


 


 

Study of Comparative Treatments for Retinal Vein Occlusion 2 (SCORE2)

 

Principal Investigator: Michael E. Rauser, MD

 

Sub-Investigators: Joseph T. Fan, MD & Mukesh B. Suthar, MD

 

 

Study Objective:  The primary objective of SCORE2 is to test for non-inferiority based on mean change from baseline in visual

 acuity letter score at Month 6 for eyes randomized to intravitreal bevacizumab every 4 weeks compared with eyes

randomized to intravitreal aflibercept every 4 weeks using a non-inferiority margin of 5 letters.  Patients might be eligible to

participate in this study if they meet the following criteria:


 
•    Diagnosed with center-involved macular edema secondary to CRVO

•    Best corrected vision E-EDTRS is between 20/40 and 20/400

•    Retinal thickness on SD-OCT measurement, defined as central subfield thickness of 300 µm or greater. If the SD-OCT

measurement is taken from a Heidelberg Spectralis Machine, the central subfield thickness should be 320 µm or greater.

•    Has no history of allergy to any anti-VEGF agent, corticosteroid, or component of the delivery vehicle.

•    Has no history of laser photocoagulation for macular edema within 3 months prior to randomization.

•    Has no History of intravitreal corticosteroid within 4 months of randomization.

 


Implantable Miniature Telescope for End-Stage AMD

 

A Prospective, Multicenter Post-Approval Study (PAS) Of Visioncare’s Implantable Miniature

 

 Telescope (By Dr. Isaac Lipshitz) In Patients With Bilateral Severe To Profound Central 

 

Vision Impairment Associated With End-Stage Age-Related Macular Degeneration

 

 

Principal Investigator: Michael E. Rauser, MD

 

 

Study Objective: The objective of the study is to assess the safety of the intraocular telescope as measured by the cumulative

 incidence of patients within 5 years after implantation experience persistent vision-impairing corneal edema.  Patients may be

 eligible to participate in this study if they meet the following criteria:


 
•    Age >=75 years

•    Best corrected vision E-EDTRS is between 20/160 and 20/800

•    Have retinal findings of geographic atrophy or disciform scar with foveal involvement

•    Have evidence of visually significant cataract (> Grade 2)

•    Agree to undergo pre-surgery training and assessment with low vision specialists in the use of an external telescope

sufficient for patient assessment and for the patient to make an informed decision

•    Achieve at least a 5-letter improvement on the ETDRS chart with an external telescope

•    Have adequate peripheral vision in the eye not scheduled for surgery

•    Agree to participate in a postoperative visual training with a low vision specialist

•    No diagnosis of Stargardt’s macular dystrophy

•    Have an central anterior chamber depth > 3.0mm

 


For more information on any of the above studies please contact one of our Research Division

 

 Coordinators:

 

•    Gisela Santiago – (909) 558-2170

•    L. Marvyn Cerdenio - (909) 558-2168

Loma Linda University Eye Institute 

Research Division

11370 Anderson Street, Suite 1800

Loma Linda, CA 92354