Clinical Trials: Providing New Hope and Opportunity in The Face of Retinal Conditions

Clinical trials are scientific medical research into the appropriateness, effectiveness and safety of new treatments in humans. The goal of clinical trials—whether for vision-related care or any other medical discipline—is to advance medical knowledge and help improve patient care. Specifically, clinical trials determine whether a new medication, device or treatment strategy…

  • Improves patient outcomes
  • Offers real benefit
  • Causes no harm

 

Designed for safety, accuracy and advancement of quality care.

Clinical trials are designed to produce the highest-quality data possible… while ensuring the safety of the patients in each study. Trials are conducted in adherence to strict standards, and they are governed and reviewed by institutional review boards (IRBs), which exist to protect patients’ health and safety.

Clinical trials are one of the last steps in the careful, detailed process of studying a new treatment. (Investigation begins in the laboratory, and promising methods may proceed to non-human testing and then human trials.) At the same time, patients enrolled in a new treatment’s clinical trial may be the first to benefit from that treatment. Every treatment in use today was investigated and approved for use through the clinical trials process, and all future medical treatments will have gone through this process.

Why consider enrolling in a retina-related clinical trial?

Retinal care, like the field of medicine itself, is always advancing and changing. New methods and medications are constantly being developed to slow disease process, improve vision outcomes, and improve quality of life. At Austin Retina Associates, we participate in clinical trials to offer new options, opportunities and hope for people who need them to protect, preserve or improve their eyesight. For individuals with few options or who aren’t seeing positive results, enrolling in a clinical trial provides access to the promising new vision therapies of tomorrow.

Clinical trials open for enrollment at Austin Retina Associates.

Our specialists are proud to take part in clinical research trials for many common retinal conditions. Below are trials for which we are currently enrolling new patients. If you’d like more information on any of the trials below, please fill out our contact form and indicate which trial you’re interested in.

Clinical Trials Ongoing

Status: Open for Enrollment

Opthea (Protocol OPT-302-1002)

ClinicalTrials.gov Identifier: NCT02543229
Intravitreal OPT-301 in combination with Ranibizumab, compared to Ranibizumab alone in patients with wAMD.

Samsung Bioepis (Protocol SB11-G31-AMD)
ClinicalTrials.gov Identifier: NCT03150589
Intravitreal SB11 (Proposed Ranibizumab biosimilar) compared to Ranibizumab alone in patients with wAMD.

Ophthotech (Protocol OPH2003) 

ClinicalTrials.gov Identifier: NCT02686658
Anti-C5 aptamer in patients with Geographic Atrophy.

Ophthotech (Protocol OPH2005)

ClinicalTrials.gov Identifier: NCT03364153
Anti-C5 aptamer in patients with Stargardt Disease.

Clearside Biomedical (Protocol CLS1003-301) “SAPPHIRE”

ClinicalTrials.gov Identifier: NCT02980874
Supra-choroidal Triamcinolone with Intravitreal Aflibercept vs sham Suprachoroidal procedure with Intravitreal Aflibercept in RVO with ME.

DRCR/JAEB (Protocol AC)

ClinicalTrials.gov Identifier: NCT03321513
Aflibercept vs. Bevacizumab + Deferred Aflibercept for the Treatment of CI-DME

Status: Closed for Enrollment

Eyegate (Protocol EGP-437-006)
Iontophorectic dexamethasone for non-infectious anterior Uveitis.

DRCR/JAEB (Protocol W)
AntiVEGF in prevention of vision threatening Diabetic Retinopathy in high risk eyes.

Aerpio Therapeutics, Inc. (Protocol AKB-9779-CI-5001) “TIME-2B”
A Novel Tie 2 Activator, AKB-9778, use once or twice daily vs sham in patients with NPDR.

Clearside Biomedical (Protocol CLS1004-201) “TYBEE”
Supra-choroidal Triamcinolone with Intravitreal Aflibercept vs sham Suprachoroidal procedure with Intravitreal Aflibercept in DME.

Novartis (Protocol RFB002/Ranibizumab) “RAINBOW”
Ranibizumab vs laser in infants with ROP.

DigiSight (Protocol DS2001510k) “PAXOS Checkup”
Mobile device self visual acuity testing vs ETDRS.

DRCR/JAEB (Protocol TX)
5 Year follow-up exam of subjects who completed DRCR protocol “T”, a comparison of Aflibercept, Bevacizumab and Ranibizumab in patients with DME.

DRCR/JAEB (Protocol AA)
Ultrawide-Field imaging vs traditional 7F fundus photography in patients with diabetic retinopathy in monitoring disease progression.

Regeneron (Protocol VGFTe-OD-1411) “PANORAMA”
Aflibercept vs sham in patients with NPDR.

Allergan (Protocol 150998-006) “SEQUOIA”
Abicipar vs Lucentis in patients with treatment-naïve CNV due to Wet AMD.

Alcon (Protocol RTH258-C001) “HAWK”
RTH258 vs Eylea in patients with treatment-naïve CNV due to Wet AMD.

Clinical Trials Completed:

F. Hoffmann La Roche/Genentech (Protocol GX29176) “CHROMA” Phase III
Lampalizumab intravitreal injection vs sham in patients with Geographic Atrophy due to Dry AMD.

Allergan (Protocol 190342-038) “BEACON”
Brimonidine DDS vs Sham in patients with Geographic Atrophy due to Dry AMD.

Regeneron (Protocol R910-3-AMD-1517) “ONYX”
Co-formulation anti-Ang2+Aflibercept for patients with treatment-naïve CNV.

F. Hoffmann La Roche/Genentech (Protocol BP29647)“AVENUE”
RO6867461 vs Lucentis in patients with treatment-naïve CNV due to Wet AMD.

Regeneron (Protocol R2176-3-AMD-1417) “CAPELLA”
REGN2176-3 vs Eylea in patients with treatment-naïve CNV due to Wet AMD.

Ophthotech (Protocol OPH1002) “ECLIPSE” Phase III
Intravitreal injections of FOVISTA in combination with Lucentis versus Lucentis as monotherapy in patients with treatment-naïve Wet AMD.

LPath (Protocol LT1009-Oph-003“NEXUS” Phase 2A
Intravitreal ISONEP (Sonepcizumab LT-1009) as monotherapy or adjunctive therapy to Lucentis, Avastin or Eylea versus Lucentis, Avastin or Eylea as monotherapy in patients with Wet AMD.

NeoVista (Protocol NVI-114) “CABERNET”
Prospective study of the Epi-Rad90 ophthalmic system  in patients with subfoveal CNV secondary to AMD.

Regeneron (Protocol VGFT-OD-0910.03)
Safety and tolerability extension study of intravitreal VEGF Trap-Eye in patients with CVN secondary to AMD.

Regeneron (Protocol VGFT-OD-0606) “VIEW”
Safety and efficacy of  intravitreal VEGF Trap versus ranibizumab in patients with CNV secondary to AMD.

Genentech (Protocol FVF3426g) “HORIZON”
Intravitreal ranibizumab extension study for patients who have completed a Genentech ranibizumab trial.

Genentech (Protocol FVF4579g)  “HARBOR”
Safety and efficacy of 0.5mg and 2.0mg  ranibizumab intravitreal injection administered monthly versus as-needed in patients with subfoveal CNV secondary to AMD.

GlaxoSmithKline (Protocol MD7110852)
Dose-evaluation study of pazopanib eye drops versus ranibizumab in patients with CNV secondary to AMD.

Acucela (Protocol 4429-201)
Safety and tolerability of oral ACU-4429 in patients with Dry AMD.

Allergan (Protocol 190342-032D-03)
Safety and efficacy of Brimonidine Tartrate PS DDS  in patients with geographic atrophy.

Allergan (Protocol 206207-019)
PS DDS  with ranibizumab in patients with CNV secondary to AMD

Allergan (Protocol 211745-001-01) “SIRIUS”
Safety and efficacy of intravitreal AGN211745 in patients with CNV secondary to AMD.

OPKO (Protocol “COBALT”)
Intravitreal bevasiranib versus Lucentis in patients with CNV secondary to AMD.

Genentech (Protocol FVF2587g) “ANCHOR”
Intravitreal ranibizumab versus Visudyne PDT in patients with CNV secondary to AMD.

Genentech (Protocol FVF2598g) “MARINA”
Intravitreal ranibizumab versus sham in occult CNV secondary to AMD.

Genentech (Protocol FVF3192g) “PIER”
Intravitreal ranibizumab in patients with minimally classic CNV secondary to AMD.

Genentech (Protocol FVF3689g) “SAILOR”
Intravitreal ranibizumab in patients with naïve or previously treated CNV secondary to AMD.

Eyetech, Inc./Pfizer (Protocol 1023) “LEVEL”
Intravitreal Macugen in patients with stable, previously treated CNV secondary to AMD.

Alcon Research , Ltd. (Protocol C-02-60)
Juxtascleral anacortave acetate versus sham CNV risk reduction study in patients with Dry AMD.

Alcon Research, Ltd. (Protocol C-01-99)
Juxtascleral anacortave acetate versus sham in patients with predominantly classic CNV secondary to AMD.

CIBA (Protocol BPD OCR-005) “VAM”
Visudyne T-IND study in patients with CNV secondary to AMD.

Miravant/Pharmacia (Protocol SNET2-98EA004)
SnET2 Photodynamic therapy versus sham in patients with CNV secondary to AMD.

Roche (Protocol BP30099) “BOULEVARD”
Anti-VEGF + anti-Ang2 for patients with DME.

Regeneron (Protocol R910-3-DME-1518) “RUBY”
Co-formulation anti-Ang2+Aflibercept for patients with DME.

Allegro (Protocol DME-202B) “Del Mar” Stage 1 and 2
Luminate vs Avastin in patients with DME.

Allegro (Protocol PVD-202) “Pacific”
Luminate vs BSS for PVD inducement in patients with NPDR.

Allergan (Protocol 150998-004) “PALM”
Evaluation of Abicipar Pegol (AGN-150998) versus ranibizumab in patients with vision loss due to diabetic macular edema.

Aerpio Therapeutics, Inc. (Protocol AKB-9778-CI-2003)
Safety and efficacy of daily, subcutaneous AKB-9778 injections as monotherapy or adjunctive therapy to ranibizumab vs. ranibizumab as monotherapy in patients with diabetic macular edema.

DRCR/JAEB (Protocol U)
Evaluation of combination corticosteroid plus anti-VEGF treatment for persistent central-involved diabetic macular edema following anti-VEGF therapy in pseudophakic eyes.

Regeneron (Protocol  VGFT-OD-1009.01) “VISTA”
Safety and efficacy of intravitreal VEGF Trap-Eye in patients with diabetic macular edema.

iCo Therapeutics (Protocol 2010-007-03-DME) “iDEAL”
Intravitreal injections of iCo-007 as monotherapy or in combination with ranibizumab or laser photocoagulation in patients with foveal diabetic macular edema.

DRCR/JAEB  (Protocol T)
Comparative effectiveness study of intravitreal aflibercept, bevacizumab and ranibizumab in patients with diabetic macular edema.

DRCR/JAEB (Protocol GEN)
Genes in Diabetic Retinopathy Project.

DRCR/JAEB (Protocol V)
Prompt laser + deferred aflibercept vs. Observation + deferred aflibercept vs. Prompt aflibercept, (1:1:1), for the treatment of diabetic macular edema in treatment-naïve patients with very good vision (20/25 or better).

DRCR (Protocol S)
Prompt PRP versus intravitreal ranibizumab with deferred PRP in patients with proliferative diabetic retinopathy.

Allergan (Protocol 206207-024)
Comparing the safety and efficacy of dexamethasone posterior segment drug delivery system (DEX PS DDS) to ranibizumab in patients with diabetic macular edema.

Genentech (Protocol FVF4170g) “RISE”
Safety and efficacy of  intravitreal ranibizumab versus sham injection in patients with clinically significant macular edema secondary to diabetes mellitus.

Allergan (Protocol 206207-011)
Dexamethasone PS DDS versus sham in patients with diabetic macular edema.

DRCR/JAEB (Protocol 1A)
Modified laser treatment in patients with diabetic macular edema.

DRCR/JAEB (Protocol B)
Observation of diabetic macular edema following scatter laser therapy.

DRCR/JAEB (Protocol F)
Triamcinolone with focal laser in patients with diabetic macular edema.

Allergan (Protocol 206207-018)
PS DDS in patients with diabetic macular edema status post vitrectomy.

Alimera Sciences , Inc. (Protocol C-01-05-001) “FAME”
Intravitreal Fluocinolone Acetonide versus sham in patients with diabetic macular edema.

Allergan (Protocol 208397-001)
Safety and efficacy of a single dose of AGN-208397 in patients with macular edema due to retinal vein occlusion.

Genentech (Protocol FVF4165g) “BRAVO”
Ranibizumab versus sham in patients with branch retinal vein occlusion.

Genentech (Protocol FVF4166g) “CRUISE”
Intravitreal ranibizumab versus sham in patients with central retinal vein occlusion.

Genentech (Protocol FVF4967g ) “SHORE”
Dosing regimens of intravitreal ranibizumab in patients with macular edema secondary to retinal vein occlusion.

Allergan (Protocol 206207-009)
Intravitreal dexamethasone PS DDS versus sham in patients with central or branch retinal vein occlusion.

Clearside Biomedical (Protocol CLS1001-301) “Peachtree”
Supra-choroidal Triamcinolone for non-infectious Uveitis.

Santen (Protocol 32-007“SAKURA”
Safety and efficacy of DE-109 for the treatment of active, non-infectious posterior segment uveitis. 

EyeGate (Protocol EGP-437-004)
Safety and efficacy of iontophoretic dexamethasone phosphate compared to prednisolone acetate 1% in patients with non-infectious anterior segment uveitis.

Alcon Research, LTD. (Protocol C-04-18)
Evaluation of BSS irrigating solution during vitrectomy.

Inspire (Protocol 06-102)
Intravitreal Denufosol in patients with rhegmatogenous retinal detachment.

Allegro Ophthalmics, LLC (Protocol VMA-202)
Safety and efficacy of intravitreal ALG-1001 vs. BSS injection in patients with symptomatic vitreomacular adhesion.

ThromboGenics (Protocol TG-MV-006) “MIVI-TRUST”
Microplasmin intravitreal injection versus sham injection in patients with vitreomacular traction.

Rohrer (Protocol 513403-T)
Pharmacokinetics and safety of lomefloxacin eye drops.

Parke-Davis (Protocol 919-220-0)
A multiple dose safety study on enoxacin eye drops.

Otsuka (Protocol 67-90-201)
Pharmacokinetics and safety of OPC-14117 eye drops.

Pharmos (Protocol P-5604:107)
Safety and efficacy of loteprednol etabonate in patients with GPC secondary to contact lens wear.

Need more information? Have questions about clinical trials or a specific study? Call Austin Retinal Associates today at 877-925-7649.