Trial Search Results
Study to Evaluate Safety and Efficacy of rhNGF Eye Drops Solution Versus Vehicle in Patients With Glaucoma
An 8 Week phase Ib, monocentric, randomized, double-masked, vehicle controlled, parallel groups, study with a 24 Week follow-up period to evaluate the safety and potential efficacy of a 180 μg/ml recombinant human nerve growth factor (rhNGF) eye drops solution versus vehicle in patients with glaucoma.
Stanford is currently accepting patients for this trial.
Dompé Farmaceutici S.p.A
- Drug: rhNGF
- Drug: Vehicle
1. Patients 18 years of age or older. Participant must understand and sign the informed
consent. If the participant's vision is impaired to the point where he/she cannot read
the informed consent document, the document will be read to the participant in its
2. Participant's clinical diagnosis must be consistent with glaucoma characterized by the
following features: a) clinical evidence of progressive RGC dysfunction and
degeneration using visual field and/or a structural modality. There must be at least 3
reliable visual fields within 14 months prior to entering into the study; b) residual
visual field preservation in at least 1 quadrant.
3. Participant must be medically able to undergo the testing required in the flowsheet of
4. Females of childbearing potential must agree to use an effective form of birth
1. Participant has another optic nerve or retinal degenerative disease or co-morbidity
causing significant vision loss, irrespective of whether it is currently treated or
untreated, that could limit the possibility of visual recovery.
2. Participant is blind in one eye.
3. Participant has a requirement of acyclovir and/or related products during study
duration. 4- Participant has evidence of corneal opacification or lack of optical
4. Participant has evidence of corneal opacification or lack of optical clarity.
5. Participant has undergone lens removal in the last 3 months, with or without
intra-ocular lens implantation, or has undergone intra-ocular lens replacement within
3 months, or has undergone any other ocular surgery within 9 months prior to
initiation of study drug.
6. Participant is receiving systemic steroids or other immunosuppressive medications.
7. Participant is currently participating in or has within the last 3 months participated
in any other clinical trial of a non-clinically approved drug by ocular or systemic
8. Participant has uveitis or other ocular inflammatory disease.
9. Participant has diabetic macular edema.
10. Participant has a history of ocular herpes zoster.
11. Participant is on chemotherapy.
12. Participant has a history of malignancy, not counting basal cell carcinomas, UNLESS it
was treated successfully 2 years prior to inclusion in the trial.
13. Known hypersensitivity to one of the components of the study or procedural
14. History of drug, medication or alcohol abuse or addiction.
15. Females of childbearing potential (those who are not surgically sterilized or post-
menopausal for at least 1 year) are excluded from participation in the study if they
meet any one of the following conditions:
1. are currently pregnant or,
2. have a positive result on the urine pregnancy test at the Screening/Baseline
3. intend to become pregnant during the study treatment period or,
4. are breast-feeding or,
5. not willing to use highly effective birth control measures, such as: Hormonal
contraceptives - oral, implanted, transdermal, or injected and/or mechanical
barrier methods - spermicide in conjunction with a barrier such as a condom or
diaphragm or IUD during the entire course of and 30 days after the study
Ages Eligible for Study
18 Years - 90 Years
Genders Eligible for Study