Ranibizumab patients will receive three monthly Ranibizumab 0.5 mg/0.05 mL injections, followed by PRN dosing, as treatment for acute pseudophakic cystoid macular edema.

Triamcinolone acetonide patients will receive PRN Triamcinolone acetonide 4 mg/0.1 mL injections, every 3 months, as treatment for acute pseudophakic cystoid macular edema.

CYSTOID MACULAR EDEMA

Intravitreal injection of Ranibizumab as treatment for acute pseudophakic cystoid macular edema. Ranibizumab patients will receive three monthly Ranibizumab 0.5 mg/0.05 mL injections, followed by PRN dosing, as treatment for acute pseudophakic cystoid macular edema.

Ranibizumab,

Intravitreal injection of Triamcinolone acetonide as treatment for acute pseudophakic cystoid macular edema. Triamcinolone acetonide patients will receive PRN Triamcinolone acetonide 4 mg/0.1 mL injections, every 3 months, as treatment for acute pseudophakic cystoid macular edema.

Triamcinolone acetonide

Soll Eye

Acute Pseudophakic Cystoid Macular Edema Treatment Trial: Intravitreal Ranibizumab Versus Triamcinolone Acetonide

To assess the safety of intravitreal R and T for the treatment of acute pseudophakic cystoid macular edema by evaluating:
Incidence and severity of ocular adverse events, as identified by eye examination
Incidence and severity of other adverse events, as identified by physical examination, subject reporting, and changes in vital signs

Mean change in spectral domain OCT CMT from baseline (microns)

Mean change in ETDRS letters from baseline (letters)

Proportion of patients with 3 line or better ETDRS letter improvement (%)

Time to 3 line ETDRS letter improvement (days)

Genentech, Inc.

Exendin 9-39 was administered intravenously (1,200 pmol/kg bolus followed by infusion at 300 pmol/kg/min).
Lipid infusion 66.7 mL Microlipid (0.5 gm/mL diluted in water to 222 ml).

Normal saline infusion was prepared to match the appearance of Exendin 9-39. Lipid infusion 66.7 mL Microlipid (0.5 gm/mL diluted in water to 222 ml).

Healthy Controls Exendin 9-39

Healthy Controls Placebo

Diabetics Exendin 9-39

Diabetics Placebo

Functional Dyspepsia Exendin 9-39

Functional Dyspepsia Placebo

Total

Sex: Female, Male

Race and Ethnicity Not Collected

Region of Enrollment

Intestinal chemosensitivity was recorded by evaluating symptoms during duodenal lipid infusion (0.5 gm/mL diluted in water to 222 mL) and placebo or the glucagon like peptide 1 (GLP-1) receptor antagonist exendin 9-39 over 2 hours. Participants reported the severity of 6 symptoms (nausea, fullness, bloating, abdominal pain, belching, and burning) at 15 minute intervals using a Visual Analogue Scale (VAS) marked 0 (minimum value) - 4 (maximum value): absent (0), light (1), moderate (2), severe (3) and intolerable(4). The scores recorded for nausea, fullness, bloating, and abdominal pain over the 2 hour infusion were averaged and reported as the mean symptom score. Higher scores mean a worse outcome.

Normal saline infusion was prepared to match the appearance of Exendin 9-39. Lipid infusion 66.7 mL Microlipid (0.5 gm/mL diluted in water to 222 ml).
Microlipid: Lipid infusion {66.7 mL Microlipid (0.5 gm/mL diluted in water to 222 ml).

Mean Intestinal Chemosensitivity to Lipids Perfusion

The time for half of the ingested solids or liquids to leave the stomach. Following a meal consisting of two eggs labeled with technetium Tc 99m sulfur colloid (1 mCi) served on one slice of bread with milk labeled with indium In111 diethylenetriaminepentaacetate (0.1 mCi), gastric emptying of solids and liquids was assessed with scintigraphy. Rapid emptying is defined as ≥ 36% emptied at one hour and delayed emptying is defined as < 76% emptied at four hours. Normal emptying is defined as amount less than rapid emptying definition but greater than delayed emptying definition.

Healthy Controls

Rate of Gastric Emptying (GE t 1/2) in Patients With Diabetes Mellitus (DM) or Non-ulcer Dyspepsia (NUD) Compared to Placebo

Normal saline infusion was prepared to match the appearance of Exendin 9-39. Lipid infusion 66.7 mL Microlipid (0.5 gm/mL diluted in water to 222 ml)

Exendin 9-39 was administered intravenously (1,200 pmol/kg bolus followed by infusion at 300 pmol/kg/min).
Lipid infusion 66.7 mL Microlipid (0.5 gm/mL diluted in water to 222 ml)

Overall Study

Dr. Adil E. Bharucha, Principal Investigator

Dyspepsia

Diabetes Mellitus With Gastrointestinal Symptoms

Exendin 9-39 will be administered intravenously (1,200 pmol/kg bolus followed by infusion at 300 pmol/kg/min).

protein-losing enteropathies/nausea

Acute Pseudophakic Cystoid Macular Edema Treatment Trial: Intravitreal Ranibizumab Versus Triamcinolone Acetonide

Gastrointestinal Sensorimotor Dysfunctions in Diabetes Mellitus

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