Southeastern Retina Associates is proud to acknowledge participation in the following
important clinical trials: (Click a trial to read a description)
A Phase III trial to determine whether the investigational drug Retaane is safe
and effective in slowing the progression of age-related macular degeneration from
the dry form to the wet form.
A phase III, Multicenter, Randomized, Double-Masked, Active Treatment-Controlled
study of the Efficacy and Safety of rhuFab V2 (Ranibizumab) Compared with Verteporfin
(Visudyne®) Photodynamic Therapy in Subjects with Predominantly Classic Subfoveal
Neovascular Age-Related Macular Degeneration.
The drug marketed as RETAANE(TM) is being assessed for its effectiveness and safety
in preventing the growth of abnormal blood vesssels under the retina. The study
will compare two doses, 15 mg and 30 mg in a posterior juxtafoveal injection procedure
given at 3 months versus 6 months.
This Phase III study directly compares treatment with Anecortave Acetate to Visudyne®,
measuring the medications' ability to stop deterioration for patients with predominantly
classic wet AMD. Completed Sept 15, 2005.
Diabetic Retinopathy Clinical Research to evaluate outcomes of two laser photocoagulation
techniques in treating patients with diabetic macular edema (DME).
Limited Macular Translocation (LMT) Vs. Photodynamic Therapy (PDT) with Visudyne®.
Johns Hopkins University School of Medicine at Wilmer Ophthalmological Institute
is conducting the study. Early reports support LMT for som patients who would not
benefit from laser treatment. Pilot study ended December 2002.
The study completion date was April 31, 2005 due to FDA approval of Macugen.
The Phase III study aims to establish a safe and effective dose of EYE001 (Macugen)
when given as intravitreal injections treating patients with clinically significant
diabetic macular edema (DME). Completion date was February 1, 2005.
EYETECH's three-year study was completed in July 2005.
The goal of this three year study is to determine if Macugen plus photodynamic therapy
(PDT) is more effective than just Macugen alone. Patients will receive either sham
PDT or PDT in combination with Macugen.
A Phase II trial in patients with recent vision loss due to macular edema secondary
to central retinal vein occlusion. The study will compare the safety and efficacy
of intravitreal injections of Macugen compared to sham injection.
This Phase III study will evaluate an anti-VEGF antibody called rhuFab (ranibizumab)
in eligible patients with age-related macular degeneration (AMD). Study patients
with minimally classic occult choroidal neovascularization (CNV) lesions secondary
to AMD are randomized to receive monthly intravitreal rhuFab injections in one of
two dosage levels.
Patients enrolled in the MARINA trial may continue in the Extension study. All patients
receive Lucentis in this study.
An oral drug manufactured by Novartis, for treatment of Diabetic Macular Edema (DME).
Patient follow-up closed November 2002.
This Phase III randomized trial will assess the safety and efficacy of 700 µg and
350 µ g Dexamethasone Posterior Segment Drug Delivery applicator System in the treatment
of macular edema following central and branch retinal vein occlusion.
This three year study assesses 700 µg, 350 µg, and sham Dexamethasone posterior
Segment Drug Delivery Applicator System for reducing swelling and improving vision.
Retinal Translocation Pilot Study (RTPS) is a surgical treatment for patients with
small CNVs secondary to age-related macular degeneration (AMD). Follow-up period
completed June 2003.
This study evaluates a surgical treatment for patients with recent onset of choroidal
neovascularization (CNV) due to age-related macular degeneration (AMD). The SST
research is sponsored by the National Eye Institute of the National Institutes of
health and conducted through Johns Hopkins University School of Medicine at the
Wilmer Ophthalmological Institute. Published results Spring 2004.
This 12 month study sponsored by Genentech compares the safety and tolerability
of Lucentis in naïve and previously treated subjects with choroidal neovascularization
secondary to AMD. Patients will be randomized to either 0.3 mg or 0.5 mg Lucentis
by intravitreal injections every month for three doses followed by as-needed re-treatment.
This three-year trial compares 1mg TA, 4mg TA, and laser photocoagulation in patients
with diabetic macular edema. The study sponsor is the DRCR Network.
Transpupilary Thermotherapy (TTT) laser treatment for predominately occult subfoveal
choroidal neovascular (CNV) membranes secondary to age-related macular degeneration
(AMD). Study completed March 2003. Southeastern Retina Associates presented our
experience at ARVO meeting May 2002. See Investigative Ophthalmology & Visual Science
, Abstract Issue, March 15, 2001, Vol 43, No 4.
This National Eye Institute sponsored trial will study the effects of Preservative-free
Triamcinolone Acetonide as an adjunct to PDT in patients with neovascular AMD.
The purpose of the Phase III Visudyne® in Occult (VIO) trial is to determine if
Visudyne® photodynamic therapy is an effective treatment for patients who have occult
with no classic subfoveal choroidal neovascularization (CNV) secondary to age-related
macular degeneration (AMD). Trial completion date May 2005.
The trial looks at the drug treatment via intravitreal injection of Vitrase for
clearing vitrous hemorrhage. Follow-up completed March 2003.
The DRCR network sponsored trial will observe patients for 3 yrs to assess the potential
benefits and risks of vitrectomy.