Retinal clinical trials

SAVE SIGHT INSTITUTE &
RETINAL CLINICAL TRIALS
SYDNEY EYE HOSPITAL
CLINICAL TRIAL OPTIONS FOR YOUR PATIENTS
CONDITION
KEY CRITERIA*
TRIAL DETAILS
Diabetic macular oedema > 300 μm; 3 yr trial VEGF Trap- medication in study eye VA ~6/7.5 – 6/60; Laser unlikely to benefit and at least (FOV2304) trial; Oedema #3 3 months since previous laser, steriods placebo controlled VA 6/12 - ~6/90. CRVO < 9months or BRVO < 12m CMT >275μm (Stratus,) >300 (Cirrus,) More Details, Patient Information Sheets, Consent Forms & PLEASE CALL Study Coordinators: 02 9382 7309 Mob 0412 338 075 sydney.edu.au/medicine/mac [email protected] Principal Investigators: Prof Mark Gillies Mob 0412 060 313 A/Prof Samantha Fraser-Bell 02 9382 7309 EXPANDED INCLUSION/EXCLUSION CRITERIA
Diabetic Macular Oedema #1
Diabetic Retinopathy
INCLUSION
INCLUSION: >18yo. Type 1 diabetes. Type 2 diabetes >5yrs & on
- DMO affecting fovea in one or both eyes where laser Rx is EXLCUSION
- Uncontrolled glaucoma, or controlled glaucoma on >1 INCLUSION
- Presence of macular edema due to non-ischemic BRVO or - IVTA within 6 months. Peribulbar TA within 3 months CRVO with onset < 9m in CRVO or <12m in BRVO. - Systemic steroid Rx equiv >5mg prednisone/day - OCT >275μm (Stratus,) >300 (Cirrus,) >320 (Spectralis) EXCLUSION
- Cataract or Lasik Sx within last 3months or expected Diabetic Macular Oedema #2
- Intravitreal injectable drug other than corticosteroids INCLUSION – DMO (Type I or II diabetes)
- Ocular Hypertension (IOP >21mmHg) of Hx of Glaucoma - Central thickness Cirrus OCT ≥300μm EXCLUSION – Laser or Anti-VEGF injections 3 months prior to
study, Cataract or other ocular surgery <3months, YAG laser Macular Telangiectasia
INCLUSION: - ≥18 yo MacTel Type 2
-vitreo-retinal surgery ,active PDR , vitreomacular traction, epiretinal membrane or pre-macular fibrosis in study eye, - HBA1c >12%,BP >160 or >95 mmHg, CVA or MI last 6 months ->2 macular laser treatments in study eye Diabetic Macular Oedema #3
INCLUSION – DMO (Type I or II diabetes)
-VA ~6/7.5-6/60 study eye - Central thickness Cirrus OCT ≥350μm -could NOT benefit from laser (or pt refuses) EXCLUSION – Laser, steroids or Anti-VEGF injections 3 months
Studies in the Clinical Trial Pipeline: prior to study, Cataract or other ocular surgery < 90 days, panretinal photocoagulation < 4 month , -pars planar vitrectomy ,active PDR , vitreomacular traction, or condition in study eye which could contribute to macular oedema - HBA1c >10%,BP >160 or >90 mmHg, CNV -> 1 med for glaucoma -IOP> 25mmHg study eye

Source: http://www.oaansw.com.au/thirdparties/DMO_RVO_Criteria.pdf