Overview
The physicians of Palmetto Retina Center are committed to participate in clinical research designed to improve therapies for the retinal diseases of all types, but particularly for the more common disorders of age-related macular degeneration, diabetic retinopathy, and retinal vein occlusions.
A listing of the various trials that we are currently participating in follows. A link to either the study sponsor’s website, the FDA’s clinical trials.gov listing of the study, or both, is provided so that one can learn more details about the study design and criteria for enrollment.
Wet Maculuar Degeneration
Harbor FVF4579g
A phase iii, double-masked, multicenter, randomized, active treatment–controlled
study of the efficacy and safety of 0.5 mg and 2.0 mg ranibizumab administered monthly
or on an as needed basis (prn) in patients with subfoveal neovascular age-related
macular degeneration.
Sponsor: Genentech
CATT-Protocol 20072006
Multi-center, randomized comparison of age-related macular degeneration treatments
trial.
Sponsor: University of Pennsylvania
OPH2000
A phase 1, ascending dose and parallel group trial to establish the safety, tolerability
and pharmacokinetic profile of multiple intravitreous injections of ARC1905 (anti-C5
aptamer) given in combination therapy with multiple doses of Lucentis® 0.5 mg/eye
in subjects with neovascular age-related macular degeneration.
Sponsor: Ophthotech
VGFT-OD-0605
A Randomized, Double Masked, Active Controlled Phase III Study of the Efficacy,
Safety, and Tolerability of Repeated Doses of Intravitreal VEGF Trap in Subjects
with Neovascular Age-Related Macular Degeneration.
Sponsor: Regeneron
VGFT-OD-0702
An Open-Label, Long-Term, Safety, and Tolerability Study of Intravitreal VEGF Trap
in Subjects with Neovascular Age-Related Macular Degeneration.
Sponsor: Regeneron
Denali CBPD952A2308
A 24-month randomized, double-masked, controlled, multicenter, phase IIIB study
assessing safety and efficacy of verteporfin (Visudyne®) photodynamic therapy administered
in conjunction with ranibizumab (Lucentis™) versus ranibizumab (Lucentis™) monotherapy
in patients with subfoveal choroidal neovascularization secondary to age-related
macular degeneration.
Sponsor: Novartis
Dry Maculuar Degeneration
GATE:C-08-36
The Safety and Efficacy of AL-8309B Ophthalmic Solution for the Treatment of Geographic
Atrophy (GA) Secondary to Age-Related Macular Degeneration (AMD).
Sponsor: Alcon
GAP (C-06-30)
The Natural History of Geographic Atrophy Progression (GAP) Secondary to Age-Related
Macular Degeneration (AMD).
Sponsor: Alcon
SRFR001
A Phase II Multicenter, Randomized, Double-masked, Placebo-Controlled, Dose-Comparison
Study of the Safety and Eficacy of Fenretinide in the Treatment of Geographic Atrophy
in Subjects with Age-Related Macular Degeneration.
Sponsor: Sirion
Diabetic Retinopathy
Protocol Number: DR-002
A Phase 2, Randomized, Double-Masked, Placebo-Controlled, Dose-Ranging Clinical
Study to Assess the Safety and Efficacy of Subconjunctival Injections of Sirolimus
in Patients with Diabetic Macular Edema Secondary to Diabetic Retinopathy.
Sponsor: Macusight
Protocol I
Intravitreal Ranibizumab or Triamcinolone Acetonide in Combination with Laser Photocoagulation
for Diabetic Macular Edema.
Sponsor: DRCR
Protocol J
Intravitreal Ranibizumab or Triamcinolone Acetonide as Adjunctive Treatment to Panretinal
Photocoagulation for Proliferative Diabetic Retinopathy.
Sponsor: DRCR
Protocol No. VGFT-OD-0706
A Double-Masked, Randomized, Controlled Study of the Safety, Tolerability and Biological
Effect of Repeated Intravitreal Administration of VEGF Trap-Eye in Patients with
Diabetic Macular Edema (DME).
Sponsor: Regeneron
Rise FVF4170g
A Phase Iii, Double-Masked, Multicenter, Randomized, Sham Injection -Controlled
Study Of The Efficacy And Safety Of Ranibizumab Injection In Subjects With Clinically
Significant Macular Edema With Center Involvement Secondary To Diabetes Mellitus.
Sponsor: Genentech
Retinal Vein Occulusion
Cruise:FVF4166g
A phase iii, multicenter, randomized, sham injection-controlled study of the efficacy and safety of ranibizumab
injection compared with sham in subjects with macular edema secondary to central retinal vein occlusion.
Sponsor: Genentech
Horizon FVF3426g
An open-label, multicenter extension study to evaluate the safety and tolerability
of ranibizumab in subjects with choroidal neovascularization (cnv) secondary to
age related macular degeneration (amd) or macular edema secondary to retinal vein
occlusion (rvo) who have completed a genentech sponsored ranibizumab study.
Sponsor: Genentech
Protocol No.: VGFT-OD-0819
A Randomized, Double Masked, Controlled Phase 3 Study of the Efficacy, Safety, and
Tolerability of Repeated Intravitreal Administration of VEGF Trap-Eye in Subjects
with Macular Edema Secondary to Central Retinal Vein Occlusion (CRVO).
Sponsor: Regeneron
Retinopathy of Prematurity
BEAT ROP
Intravitreal Bevacizumab (avastintm) Injections Versus Conventional Laser Surgery
for Vision-Threatening Retinopathy of Prematurity: a Prospective, Randomized, Non-Blinded,
Controlled, Multi-Center, Clinical Trial.
Sponsor: The University of Texas Health Science Center, Houston
