Neoadjuvant administration of IDH305 at 550 mg BID for 6 weeks followed by surgical resection at 6 weeks. If there is no evidence of progressive disease at 6 weeks (clinical, radiographic or histopathologic exam), the patient will continue on IDH305 at 550 mg BID post-operatively for a maximum of 11 additional 28 day cycles. Subsequent assessment of disease will occur every 2 months starting in Cycle 2.

Patients who have inoperable tumors but measurable 2HG pre-treatment will be treated with IDH305 at 550 mg BID x 6 weeks. If there is adequate sustained knockdown of 2HG on MRS and disease is stable or improved, then the patient will continue on treatment for a maximum of 11 additional 28 day cycles.

Glioma

IDH305

Phase 2 Study of IDH305 in Low Grade Gliomas

A Phase 2 Study of the IDH1 Inhibitor, IDH305, for the Treatment of IDH1 Mutated Low Grade Glioma Patients Who Have Measurable 2HG by MR Spectroscopy

Number of participants treated with IDH305 leads to sustained knockdown of 2HG by MR spectroscopy from Baseline.

Number of participants with radiographic and clinical response to knockdown of 2HG by IDH305 compared to Baseline.

University of Texas Southwestern Medical Center

Diabatic maculopathy comes to the edematous or tractional form. It is believed that epiretinal membranes are comprised from glial components. The processes of these cells may invade through the internal limiting membrane of the retina to the vitreous causing the vitreoretinal adhesion and anomalous posterior detachment of vitreous (APVD). In the macula, APVD causes vitreo-macular traction syndrome, which results in diffuse diabetic macular edema. If vitreoschisis is present, a place of dissection is crucial. If break occurs in front of the hyalocytes remaining on the retinal surface, the vitreous layer is thick and easily shrinks concentrically, which results in the formation of epimacular membrane.

Diffuse Diabetic Macular Edema

Three port pars plana vitrectomy is performed by one surgeon (JR). Induction of PVD is initiated by active suction with the vitrectomy probe over the ONH and continued peripherally. Peeling of the epimacular tissue and ILM is performed by grasping the flap of the ILM with an eckhardts forceps. Trypan Blue is used to stain the ILM. Peripheral laser endophotocoagulation is performed in cases of avascular areas based on FA, active neovascularization, peripheral retinoschisis or retinal breaks. All eyes have a 1,25 mg/0,05 ml bevacizumab injection into vitreous cavity and SF6 gas tamponade at the end of the procedure. Even of absence of cataract formation, a combined procedure is performed because of exactly peripheral vitreous shaving and prevention of cataract formation.

Triple therapy for diffuse diabetic macular edema

Military Institute of Medicine

Triple Therapy for Diffuse Diabetic Macular Edema

Combined Phako-Vitrectomy With ILM Peeling, Retinal Endophotocoagulation, and Intraoperative Use of Bevacizumab for Diffuse Diabetic Macular Edema

The best corrected visual acuity (BCVA) for ETDRS chart and central macular thickness (CMT) are assessed preoperatively and during the follow-up period. OCT is performed 1 mm and 6 mm diameter topography centered at the patient fixation point. We evaluate mean central retinal thickness and central retinal volume 1 mm and 6 mm in diameter.

The best corrected visual acuity (BCVA) for ETDRS chart, results are converted to log MAR for statistical analysis. The central macular thickness (CMT) are assessed 1 mm diameter topography centered at the patient fixation point for OCT-SLO. We evaluate mean central retinal thickness and central retinal volume 1 mm and 6 mm in diameter.

A follow-up examination include: The best corrected visual acuity (BCVA) for ETDRS chart, results are converted to log MAR for statistical analysis. The central macular thickness (CMT) are assessed 1 mm diameter topography centered at the patient fixation point for OCT-SLO. We evaluate mean central retinal thickness and central retinal volume 1 mm and 6 mm in diameter.

The demographic characteristics of the patients including: age, grender, metabolic condition: HbA1c level, body mass index, presence of systemic hypertension, ocular condition: diabetic retinopathy stage, previous laser, presence of viteomacular traction or epiretinal membrane are recorded to eveluate the possible association with chance in postoperative BCVA.

Department of Ophthalmology

Military Institute of Medicine, Poland

Multiple Sclerosis

ACTHAR

UT Southwestern Medical Center

Modeling and Treating the Pathophysiology of Demyelination in Multiple Sclerosis

Elliot Frohman

Professor

Mallinckrodt

15 patients with clinical significant macular edema receive an injection of 2,5 mg Avastin every month. After three initial injections of Avastin re-injection is performed if the central retinal thickness measured with optical coherence tomography (Stratus OCT, Zeiss) stays more than 300 microns. If the Central retinal thickness decreases under 300 microns a sham injection is performed.

30 patients with a clinical significant diabetic macular edema receive an intraocular injection of 8mg triamcinolone at baseline under sterile conditions. 1 and 2 month after the baseline injection, patients receive a sham injection. After three month re-injection of 8mg Triamcinolone is performed if the central retinal thickness measured with optical coherence tomography (Stratus OCT, Zeiss) stays more than 300 microns. If the Central retinal thickness decreases under 300 microns patients will receive a sham injection. In between two injection of 8mg Triamcinolone must be an temporal interval of at least 3 months.

15 patients with clinical significant macular edema receive an injection of 0,5 mg Lucentis every month. After three initial injections of Lucentis re-injection is performed if the central retinal thickness measured with optical coherence tomography (Stratus OCT, Zeiss) stays more than 300 microns. If the Central retinal thickness decreases under 300 microns a sham injection is performed.

After a loading dose of three monthly injections of 2.5mg Avastin, PRN treatment based on predefined morphological and functional retreatment criteria, that were reassessed monthly.

Avastin

Baseline injection of 8mg intravitreally applied triamcinolone was followed by two sham injections at month 1 and 2. Sham injections were only mimicked without penetration of the ocular globe after the same pre-injection procedure. Beginning at month 3 patients were treated as needed (PRN) based on predefined morphological and functional retreatment criteria, that were reassessed monthly. Triamcinolone was injected no more than every three months intermitted by sham injections to maintain patient masking.

Triamciolone

After a loading dose of three monthly injections of 0.5mg Lucentis, PRN treatment based on predefined morphological and functional retreatment criteria, that were reassessed monthly.

Lucentis

Total

Sex: Female, Male

Efficacy of the treatment with intravitreal administered injections of anti VEGF (Bevacizumab (Avastin®) or Ranibizumab (Lucentis®) ) compared with triamcinolone (Volon A®) in patients with diabetic macular edema is examined using Visual acuity measurements with ETDRS charts: units: logMAR; scale range: -0.1 to 1.0; higher values are considered worse outcome

Loading dose of three monthly 2.5mg Avastin injections followed by PRN treatment.

Initial 8mg intravitreally applied Triamcinolone followed by two sham injections. PRN treatment from month 3.

Loading dose of three monthly 0.5mg Lucentis injections followed by PRN treatment.

Efficacy of the Treatment Assessed With Visual Acuity Measured by ETDRS Charts.

Efficacy of the treatment with intravitreal administered injections of anti VEGF (Bevacizumab (Avastin®) or Ranibizumab (Lucentis®) ) compared with triamcinolone (Volon A®) in patients with diabetic macular edema is measured with standard Optical Coherence Tomography - (OCT): units: µm; scale range: 200-800; higher values are considered worse outcome

Efficacy of the Treatment Assessed by Standard Optical Coherence Tomography (OCT)

Area of leakage and non perfusion is measured in FA, morphologic details like presence of cysts or sub retinal fluid is evaluated in OCT. Data is still under evaluation.

To Explore the Structural Mechanisms of the Effect on Diabetic Macular Edema as Assessed by Fluorescein Angiography and Ultra High-resolution Optical Coherence Tomography. To Observe the Changes in Retinal Function a Microperimetry is Assessed.

15 patients with clinical significant macular edema receive an injection of 2,5 mg Avastin every month. After three initial injections of Avastin re-injection is performed following a predefined protocol.

30 patients with a clinical significant diabetic macular edema receive an intraocular injection of 8mg triamcinolone at baseline under sterile conditions. 1 and 2 month after the baseline injection, patients receive a sham injection. After three month re-injection of 8mg Triamcinolone is performed as needed following a predefined protocol. In between two injection of 8mg Triamcinolone must be an temporal interval of at least 3 months.

15 patients with clinical significant macular edema receive an injection of 0,5 mg Lucentis every month. After three initial injections of Lucentis re-injection is performed as needed following a predefined protocol.

Bevacizumab vs Triamcinolone

Ranibizumab vs Triamcinolone

Dr. Katharina Kriechbaum

Patients with clinical significant macular edema receive an injection of 2,5 mg Avastin every month. After three initial injections of Avastin re-injection is performed as needed.

30 patients with a clinical significant diabetic macular edema receive an intraocular injection of 8mg triamcinolone at baseline under sterile conditions. 1 and 2 month after the baseline injection, patients receive a sham injection. After three month re-injection of 8mg Triamcinolone is performed if needed. In between two injection of 8mg Triamcinolone must be an temporal interval of at least 3 months.

15 patients with clinical significant macular edema receive an injection of 0,5 mg Lucentis every month. After three initial injections of Lucentis re-injection is performed if needed.

Diabetic Macular Edema

The intravitreal injection of Bevacizumab (Avastin®) is performed in the operating room under sterile conditions. The patient receives an initial drop of lidocaine 4% into the study eye followed by betaisodona solution. Then the lid margins, the lids and the periocular skin are washed carefully with betaisodona. The eye is draped in a sterile fashion. A sterile lid speculum is inserted by the surgeon. Another drop of betaisodona is applied into the eye. A circle is used to mark the injection site 3.5mm from the limbus in the inferior temporal quadrant. The injection is given at the marked site, slowly, at a 90 degree angle. After injecting the total volume of 0.1ml the needle is slowly withdrawn. Another drop of betaisodona is given as well as an antibiotic/steroid ointment.

Bevacizumab (Avastin)

The intravitreal injection of triamcinolone (Volon A®) is performed in the operating room under sterile conditions at baseline. The patient receives an initial drop of lidocaine 4% into the study eye followed by betaisodona solution. Then the lid margins, the lids and the periocular skin are washed carefully with betaisodona. The eye is draped in a sterile fashion. A sterile lid speculum is inserted by the surgeon. Another drop of betaisodona is applied into the eye. A circle is used to mark the injection site 3.5mm from the limbus in the inferior temporal quadrant. The injection is given at the marked site, slowly, at a 90 degree angle. After injecting the total volume of 0.1ml the needle is slowly withdrawn. Another drop of betaisodona is given as well as an antibiotic/steroid ointment.

Triamcinolone

Patients receiving sham intravitreal injections do not receive an actual injection of study drug. The injecting physician performing the sham injection will be unmasked to the treatment to the treatment assignment regarding active versus sham. The injecting physician will perform the same pre-injection procedures for the patients receiving bevacizumab or triamcinolone, An empty syringe without a needle will be used in the sham injection. The injecting physician will mimic an intraocular injection by making contact with the conjunctiva and applying pressure without the needle. Immediately following the sham injection, the injecting physician will perform the same post-injection procedures as those performed on patients receiving bevacizumab or triamcinolone.

Sham

The intravitreal injection of Ranibizumab (Lucentis®) is performed in the operating room under sterile conditions. The patient receives an initial drop of lidocaine 4% into the study eye followed by betaisodona solution. Then the lid margins, the lids and the periocular skin are washed carefully with betaisodona. The eye is draped in a sterile fashion. A sterile lid speculum is inserted by the surgeon. Another drop of betaisodona is applied into the eye. A circle is used to mark the injection site 3.5mm from the limbus in the inferior temporal quadrant. The injection is given at the marked site, slowly, at a 90 degree angle. After injecting the total volume of 0.05ml the needle is slowly withdrawn. Another drop of betaisodona is given as well as an antibiotic/steroid ointment.

Dept. of Ophthalmology, Medical University of Vienna

Intraocular Anti-VEGF Compared With Intraocular Triamcinolone in Patients With Diabetic Macular Edema

A Randomized, Double-masked Study With Intraocular Anti-VEGF (Avastin®/Lucentis®) Compared With Intraocular Triamcinolone (Volon A®) in Patients With Clinical Significant Diabetic Macular Edema

Katharina Kriechbaum

Ass.Prof.Dr.

Medical University of Vienna

Diabetic Retinopathy

Proliferative Diabetic Retinopathy

bevacizumab

Ranibizumab

Department of Ophthalmology, Medical University of Vienna

Bevacizumab Versus Ranibizumab for Diabetic Retinopathy

A Randomized, Double-masked Study With Intraocular Bevacizumab Compared With Intravitreal Ranibizumab in Patients With Persistent Diabetic Macular Edema or Persistent Active Neovascularisation Following Lasercoagulation

gliosis/edém

Phase 2 Study of IDH305 in Low Grade Gliomas

Triple Therapy for Diffuse Diabetic Macular Edema

Modeling and Treating the Pathophysiology of Demyelination in Multiple Sclerosis

Intraocular Anti-VEGF Compared With Intraocular Triamcinolone in Patients With Diabetic Macular Edema

Bevacizumab Versus Ranibizumab for Diabetic Retinopathy

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