Clinical Trials

Retina Associates have participated in numerous nationwide studies involving different retinal diseases and their treatment over the past 15 years. We are presently are involved in a “wet” macular degeneration study and diabetic retinopathy studies. Please see the list of our current studies.

Our past studies have included new treatments for macular degeneration, diabetic retinopathy and vein occlusions. Retina Associates will continue to commit time and energy to the advance treatments related to the retina to serve our patients.

For more information regarding our studies, please contact: Martha Kelley, Study Coordinator at 314-839-1211


OHR-1601- WET AMD

A Phase III, Study of the Efficacy and Safety of Squalamine Lactate Ophthalmic Solution, 0.2% Twice Daily in Subjects with Neovascular Age-Related Macular Degeneration.

We are not presently enrolling patients into this study. For more information please contact Martha Kelley, Study Coordinator at 314-839-1211.

Inclusion Criteria:

  1. 50 years or over
  2. Meet the following criteria in the study eye:
    • A diagnosis of choroid neovascularization (CNV) secondary to AMD with CNV comprising at least 50% of the total lesion area on flurorescein angiography (FA). The CNV lesion may contain classic and/or occult CNV; however, the occult CNV component must measure less than 10.0 mm2 as assessed on FA by the investigator and confirmed by the Clinical Research Coordinator (CRC).
    • Central subfield thickness (spectral domain [SD]-OCT central 1 mm) of > 300 um
    • No previous treatment in the study eye for neovascular AMD
    • Presence of subretinal or intraretinal fluid (cystic spaces) on OCT
    • Best-corrected visual acuity (BCVA) 20/40 to 20/320 (73- to 24-letter score on the Early Treatment of Diabetic Retinopathy Study [ETDRS] chart)

Exclusion Criteria:

  1. Neovascularization secondary to any condition other than wet AMD in the study eye
  2. Blood occupying greater that 50% of the AMD lesion or blood > 1.0 mm2 underlying the fovea in the study eye
  3. Pigment epithelial detachment without associated subretinal fluid and/or cystic retinal changes in the study eye
  4. Fibrosis, atrophy or retinal epithelial tear in the center of the fovea of the study eye, or any other condition preventing visual acuity (VA) improvement
  5. Any prior treatment in the study eye for neovascular AMD, including treatment with IVT bevacizumab, ranbizumab, aflibercept, photodynamic therapy (PDT), submacular surgery, intraocular steroid or any antiangiogenic drug for AMD
  6. Confounding ocular conditions in the study eye that may affect interpretation of OCT, VA or assessment of macular appearance (e.g. cataract, epiretinal membrane, retinal vascular disease)
  7. Clinical evidence of diabetic retinopathy or diabetic macular edema in the study eye
  8. Uncontrolled glaucoma in the study eye or currently receiving topical glaucoma medication in the study eye
  9. Current ocular or periocular infection in the study eye
  10. BCVA worse than 20/200 (less than 34 letters) in the fellow (non-study) eye

 


Regeneron Diabetic Retinopathy Study

A p\Phase 3, Doubled-Masked, Randomized Study of the Efficacy and Safety of Intravitreal Aflibercept Injection in Patients with Moderately Severe to Severe Nonproliferative Diabetic Retinopathy

Study is closed to enrollment

Inclusion Criteria:

  1. Men or Women > 18 years of age with type 1 or 2 diabetes mellitus who have moderately severe to severe NPDR (DRSS levels 47 or 53), confirmed by the central reading center, in whom PRP can be safely deferred for at least 6 months per the investigator.
  2. BCVA ETDRS letter score in the study eye of > 69 letters (approximate Snellen equivalent of 20/40 or better)

Exclusion Criteria:

  1. Presence of DME threatening the center of the macula in the study eye.
  2. Evidence of retinal neovascularization on clinical examination or FA
  3. Any prior focal or grin laser photocoagulation or any prior PRP in the study eye.
  4. Any prior systemic anti-VEGF treatment or IVT anti-VEGF treatment in the study eye
  5. Any prior intraocular steroid injection in the study eye
  6. History of vitreoretinal surgery in the study eye

 


Regeneron - Wet ARMD

This study is closed to enrollment

A Phase 2, Double-Masked, Randomized, ConTrolled, Multiple-Dose, Regimen- Ranging Study of the Efficacy and Safety of Intravitreal REGN2176-3 in Patients with Neovascular Age-Related Macular Degeneration.