anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: MK-1496
Trial phase: Phase 1
SMILES: C[C@H](N)c1ccc([C@H](O)CNC(C)(C)C)cc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 3
Group description: Participants receiving MK-1496 80 mg on Day 1 of each 21-day cycle
Eligibility criteria:
Inclusion Criteria

Participant must have a histologically-confirmed metastatic or locally advanced solid tumor that has failed to respond to standard therapy, progressed despite standard therapy, or for which standard therapy does not exist.
Participant must have Performance Status 0 or 1.
Participant must have adequate organ function.

Exclusion Criteria

Participant has had chemotherapy, radiotherapy, or biological therapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to registration.
Participant has received 4 or greater regimens of chemotherapy (adjuvant therapy and incomplete 1 cycle treatment are not considered as 1 regimen).
Participant has known hypersensitivity to the components of study drug or its analogs.
Participant has had prescription or non-prescription drugs or other products known to be moderate or potent inhibitors/inducers of cytochrome P (CYP)3A4, or substrates of CYP3A4 with narrow therapeutic window.
Intervention: MK-1496
Trial phase: Phase 1
SMILES: C[C@H](N)c1ccc([C@H](O)CNC(C)(C)C)cc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 1
Group description: Participants receiving MK-1496 120 mg on Day 1 of each 21-day cycle
Eligibility criteria:
Inclusion Criteria

Participant must have a histologically-confirmed metastatic or locally advanced solid tumor that has failed to respond to standard therapy, progressed despite standard therapy, or for which standard therapy does not exist.
Participant must have Performance Status 0 or 1.
Participant must have adequate organ function.

Exclusion Criteria

Participant has had chemotherapy, radiotherapy, or biological therapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to registration.
Participant has received 4 or greater regimens of chemotherapy (adjuvant therapy and incomplete 1 cycle treatment are not considered as 1 regimen).
Participant has known hypersensitivity to the components of study drug or its analogs.
Participant has had prescription or non-prescription drugs or other products known to be moderate or potent inhibitors/inducers of cytochrome P (CYP)3A4, or substrates of CYP3A4 with narrow therapeutic window.
Intervention: MK-1496
Trial phase: Phase 1
SMILES: C[C@H](N)c1ccc([C@H](O)CNC(C)(C)C)cc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 3
Group description: Participants receiving MK-1496 20 mg on Days 1, 3, 8, 10, 15, and 17 of each 28-day cycle
Eligibility criteria:
Inclusion Criteria

Participant must have a histologically-confirmed metastatic or locally advanced solid tumor that has failed to respond to standard therapy, progressed despite standard therapy, or for which standard therapy does not exist.
Participant must have Performance Status 0 or 1.
Participant must have adequate organ function.

Exclusion Criteria

Participant has had chemotherapy, radiotherapy, or biological therapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to registration.
Participant has received 4 or greater regimens of chemotherapy (adjuvant therapy and incomplete 1 cycle treatment are not considered as 1 regimen).
Participant has known hypersensitivity to the components of study drug or its analogs.
Participant has had prescription or non-prescription drugs or other products known to be moderate or potent inhibitors/inducers of cytochrome P (CYP)3A4, or substrates of CYP3A4 with narrow therapeutic window.
Intervention: MK-1496
Trial phase: Phase 1
SMILES: C[C@H](N)c1ccc([C@H](O)CNC(C)(C)C)cc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 3
Group description: Participants receiving MK-1496 40 mg on Days 1, 3, 8, 10, 15, and 17 of each 28-day cycle
Eligibility criteria:
Inclusion Criteria

Participant must have a histologically-confirmed metastatic or locally advanced solid tumor that has failed to respond to standard therapy, progressed despite standard therapy, or for which standard therapy does not exist.
Participant must have Performance Status 0 or 1.
Participant must have adequate organ function.

Exclusion Criteria

Participant has had chemotherapy, radiotherapy, or biological therapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to registration.
Participant has received 4 or greater regimens of chemotherapy (adjuvant therapy and incomplete 1 cycle treatment are not considered as 1 regimen).
Participant has known hypersensitivity to the components of study drug or its analogs.
Participant has had prescription or non-prescription drugs or other products known to be moderate or potent inhibitors/inducers of cytochrome P (CYP)3A4, or substrates of CYP3A4 with narrow therapeutic window.
Intervention: MK-1496
Trial phase: Phase 1
SMILES: C[C@H](N)c1ccc([C@H](O)CNC(C)(C)C)cc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 6
Group description: Participants receiving MK-1496 80 mg on Days 1, 3, 8, 10, 15, and 17 of each 28-day cycle
Eligibility criteria:
Inclusion Criteria

Participant must have a histologically-confirmed metastatic or locally advanced solid tumor that has failed to respond to standard therapy, progressed despite standard therapy, or for which standard therapy does not exist.
Participant must have Performance Status 0 or 1.
Participant must have adequate organ function.

Exclusion Criteria

Participant has had chemotherapy, radiotherapy, or biological therapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to registration.
Participant has received 4 or greater regimens of chemotherapy (adjuvant therapy and incomplete 1 cycle treatment are not considered as 1 regimen).
Participant has known hypersensitivity to the components of study drug or its analogs.
Participant has had prescription or non-prescription drugs or other products known to be moderate or potent inhibitors/inducers of cytochrome P (CYP)3A4, or substrates of CYP3A4 with narrow therapeutic window.
Intervention: MK-1496
Trial phase: Phase 1
SMILES: C[C@H](N)c1ccc([C@H](O)CNC(C)(C)C)cc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 2
Group description: Participants receiving MK-1496 100 mg on Days 1, 3, 8, 10, 15, and 17 of each 28-day cycle
Eligibility criteria:
Inclusion Criteria

Participant must have a histologically-confirmed metastatic or locally advanced solid tumor that has failed to respond to standard therapy, progressed despite standard therapy, or for which standard therapy does not exist.
Participant must have Performance Status 0 or 1.
Participant must have adequate organ function.

Exclusion Criteria

Participant has had chemotherapy, radiotherapy, or biological therapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to registration.
Participant has received 4 or greater regimens of chemotherapy (adjuvant therapy and incomplete 1 cycle treatment are not considered as 1 regimen).
Participant has known hypersensitivity to the components of study drug or its analogs.
Participant has had prescription or non-prescription drugs or other products known to be moderate or potent inhibitors/inducers of cytochrome P (CYP)3A4, or substrates of CYP3A4 with narrow therapeutic window.
Intervention: Rebamipide
Trial phase: Phase 3
ATC code: A02BX14
SMILES: O=C(NC(Cc1cc(=O)[nH]c2ccccc12)C(=O)O)c1ccc(Cl)cc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 93
Group description: Instillation,4 times/day for 4 weeks

OPC-12759 Ophthalmic suspension : OPC-12759 Ophthalmic suspension 2%
Eligibility criteria:
Inclusion Criteria:

Out patient
Subjective complaint of dry eye that has been present for minimum 20 months
Ocular discomfort severity is moderate to severe
Corneal - conjunctival damage is moderate to severe
Unanesthetized Schirmer's test score of 5mm/5minutes or less
Best corrected visual acuity of 0.2 or better in both eyes

Exclusion Criteria:

Presence of anterior segment disease or disorder other than that associated with keratoconjunctivitis sicca
Ocular hypertension patient or glaucoma patient with ophthalmic solution
Anticipated use of any topically-instilled ocular medications or patients who cannot discontinue the use during the study
Anticipated use of contact lens during the study
Patient with punctal plug
Any history of ocular surgery within 12 months
Female patients who are pregnant,possibly pregnant or breast feeding
Known hypersensitivity to any component of the study drug or procedural medications
Receipt of any investigational product within 4 months.
Intervention: Misoprostol
Trial phase: Not Applicable
ATC code: A02BB01 | G02AD06 | M01AE56
SMILES: CCCCC(C)(O)C/C=C/[C@H]1[C@H](O)CC(=O)[C@@H]1CCCCCCC(=O)OC
Sex: Female
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 108
Group description: Misoprostol 400 micrograms inserted vaginally or buccally, per the participants desire.
Eligibility criteria:
Inclusion Criteria:

18 years old or older
negative pregnancy test
no prior pregnancies beyond 14 6/7 weeks
no PID in last 3 months
no current cervicitis
be willing to follow-up in 1-2 months for an IUD string check.

Exclusion Criteria:

active cervical infection
current pregnancy
prior pregnancy beyond 14 weeks gestation
known uterine anomaly
fibroid uterus distorting uterine cavity
copper allergy/Wilson's disease (for Paragard)
undiagnosed abnormal uterine bleeding
cervical or uterine cancer.
Intervention: ESLICARBAZEPINE ACETATE
Trial phase: Phase 1
SMILES: CC(=O)O[C@H]1Cc2ccccc2N(C(N)=O)c2ccccc21
Sex: Female
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 20
Group description: 15-day treatment with ESL 800 mg once daily, with co administration of a single oral dose of Microginin® on Day 14 of the relevant dosing period, to assess impact of ESL on pharmacokinetics of the combined oral contraceptive.

eslicarbazepine acetate and Microginon®: eslicarbazepine acetate: once-daily oral dose of 800 mg on days 1- 15 of treatment period.

Microginon®: single oral dose on day 14 of treatment period
Eligibility criteria:
Inclusion Criteria:

Pre-menopausal female subjects
Age 18-40 years, inclusive
Body mass index (BMI) 19-30 kg/m2, inclusive
Healthy as determined by pre-study medical history, physical examination, vital signs, complete neurological examination and 12-lead ECG
Negative tests for HBsAg, anti-HCVAb and HIV-1 and HIV-2 Ab at screening
Negative urine pregnancy test at screening and admission to each treatment period.
Using one of the following methods of contraception: double barrier or intrauterine device

Exclusion Criteria:

Subjects who have any contra-indication to the use of oral contraceptives
History or presence of clinically relevant diseases, disorders or surgical history
History of alcoholism or drug abuse
Have used medicines within two weeks of admission to first period that may affect the safety or other study assessments, in the investigator's opinion
Intervention: ESLICARBAZEPINE ACETATE
Trial phase: Phase 1
SMILES: CC(=O)O[C@H]1Cc2ccccc2N(C(N)=O)c2ccccc21
Sex: All
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 7
Group description: Eslicarbazepine acetate (ESL) 600 mg QD morning from Day 1-3 and 1200 mg ESL QD morning from Day 4-9

Eslicarbazepine acetate: Oral administration 600 mg QD morning from Day 1-3 and 1200 mg from Day 4-9
Eligibility criteria:
Inclusion Criteria:

Healthy subjects
Aged 18-55 years
Body mass index (18.5-29 kg/m3)
Intervention: 11beta-Hydroxyandrostenedione
Trial phase: Phase 3
SMILES: CC12CC(O)C3C(CCC4=CC(=O)CCC43C)C1CCC2=O
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 147
Group description: Norethisterone, Ethinyl Estradiol

NPC-01: This study consist of the following steps.

Step 1(Norethisterone 0.6mg, Ethinyl Estradiol 0.035mg):From first study medication to 3th menstrual cycles.

Step 2(Norethisterone 1mg, Ethinyl Estradiol 0.035mg):

After interim analysis of the results of step 1, in the case of the efficacy results meet prespecified criterion, same dose level will be continued to 13th menstrual cycles including step 1. If the results do not meet prespecified criterion, the dose will be increased to Norethisterone 1mg, Ethinyl Estradiol 0.035mg and be continued newly until 13th menstrual cycle from this point.
Eligibility criteria:
Inclusion Criteria:

Dysmenorrhea associated with endometriosis

Exclusion Criteria:

Severe hepatopathy
Pregnant woman
Intervention: Misoprostol
Trial phase: Phase 4
ATC code: A02BB01 | G02AD06 | M01AE56
SMILES: CCCCC(C)(O)C/C=C/[C@H]1[C@H](O)CC(=O)[C@@H]1CCCCCCC(=O)OC
Sex: Female
Age groups: Child | Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 176
Group description: Women with hypotonic labor and a clinical decision to proceed with labor augmentation will receive oral misoprostol.

Misoprostol : 75 micrograms orally every 4 hours for up to 2 doses.
Eligibility criteria:
Inclusion Criteria:

Clinical decision to augment labor
Gestational age > than or equal to 36 weeks
Singleton gestation
Cephalic presentation
Reassuring fetal heart rate tracing
Cervical dilation between 4 and 8 cm
Ruptured membranes with clear amniotic fluid
Intrauterine pressure catheter in place
Less than 200 MVUs in a 10 minute period
5 or fewer contractions in a 10 minute period
English or Spanish speaking patient

Exclusion Criteria:

Non-reassuring fetal heart rate tracing at time of enrollment
Meconium stained amniotic fluid
Previous uterine incision
Maternal fever (defined as greater than 37.9 C)
Known fetal anomalies
Placenta previa or unexplained vaginal bleeding
Estimated fetal weight of 4,500 grams or more
Abnormal maternal bony pelvis
Grandmultiparity
Intervention: Tecovirimat
Trial phase: Phase 2
ATC code: J05AX24
SMILES: O=C(NN1C(=O)[C@@H]2[C@@H]3C=C[C@@H]([C@H]4C[C@@H]34)[C@@H]2C1=O)c1ccc(C(F)(F)F)cc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 45
Group description: 400 mg ST-246 (2 x 200 mg capsules) given as a single daily oral dose to 45 subjects for 14 days.
Eligibility criteria:
Inclusion Criteria:

18 - 75 yrs
Healthy volunteer
Ability to consent
Available for clinical follow-up for study
Not taking other medications
Adequate venous access
Using adequate birth control; negative pregnancy test
Able and willing to avoid alcohol for screening and study duration

Exclusion Criteria:

Inability to swallow study medication
Pregnant or breast-feeding
Medical condition, e.g., asthma, hypertension, angioedema, traumatic brain injury other than concussion, bleeding disorder, blood dyscrasia, idiopathic seizures, cardiac disease that limits activity, diabetes, active malignancy, Hepatitis B or C, HIV or AIDS, chronic microbial infection,
History of drug allergy that contraindicates study participation
Medical, psychiatric, social, occupational or other reason that jeopardizes the safety/rights of participant or renders he/she unable to comply with the protocol (including drug or alcohol abuse, or homelessness)
Clinically abnormal ECG
Has or will participate in a clinical trial or experimental treatment within 30 days of, or during, the study
Cannot or will not do physical exercise 24 hrs before and after PK days
Will not consume grapefruit/grapefruit juice during study
Vaccination within 2 wks of screening, or planned before Day 42 of study
Treatment with prednisone or equivalent immunosuppressant/modulatory drug <3 mths before screening
Clinically significant physical exam and lab results <2weeks from 1st study drug dose
Intervention: Tecovirimat
Trial phase: Phase 2
ATC code: J05AX24
SMILES: O=C(NN1C(=O)[C@@H]2[C@@H]3C=C[C@@H]([C@H]4C[C@@H]34)[C@@H]2C1=O)c1ccc(C(F)(F)F)cc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 46
Group description: 600 mg ST-246 (3 x 200 mg capsules) given as a single daily oral dose to 46 subjects for 14 days.
Eligibility criteria:
Inclusion Criteria:

18 - 75 yrs
Healthy volunteer
Ability to consent
Available for clinical follow-up for study
Not taking other medications
Adequate venous access
Using adequate birth control; negative pregnancy test
Able and willing to avoid alcohol for screening and study duration

Exclusion Criteria:

Inability to swallow study medication
Pregnant or breast-feeding
Medical condition, e.g., asthma, hypertension, angioedema, traumatic brain injury other than concussion, bleeding disorder, blood dyscrasia, idiopathic seizures, cardiac disease that limits activity, diabetes, active malignancy, Hepatitis B or C, HIV or AIDS, chronic microbial infection,
History of drug allergy that contraindicates study participation
Medical, psychiatric, social, occupational or other reason that jeopardizes the safety/rights of participant or renders he/she unable to comply with the protocol (including drug or alcohol abuse, or homelessness)
Clinically abnormal ECG
Has or will participate in a clinical trial or experimental treatment within 30 days of, or during, the study
Cannot or will not do physical exercise 24 hrs before and after PK days
Will not consume grapefruit/grapefruit juice during study
Vaccination within 2 wks of screening, or planned before Day 42 of study
Treatment with prednisone or equivalent immunosuppressant/modulatory drug <3 mths before screening
Clinically significant physical exam and lab results <2weeks from 1st study drug dose
Intervention: INSULIN DETEMIR
Trial phase: Phase 4
ATC code: A10AE05
SMILES: CCCCCCCCCCCCCC(=O)NCCCC[C@H](NC(=O)[C@@H]1CCCN1C(=O)[C@@H](NC(=O)[C@H](Cc1ccc(O)cc1)NC(=O)[C@H](Cc1ccccc1)NC(=O)[C@H](Cc1ccccc1)NC(=O)CNC(=O)[C@H](CCCNC(=N)N)NC(=O)[C@H](CCC(=O)O)NC(=O)CNC(=O)[C@@H]1CSSC[C@@H](C(=O)N[C@@H](CC(N)=O)C(=O)O)NC(=O)[C@H](Cc2ccc(O)cc2)NC(=O)[C@H](CC(N)=O)NC(=O)[C@H](CCC(=O)O)NC(=O)[C@H](CC(C)C)NC(=O)[C@H](CCC(N)=O)NC(=O)[C@H](Cc2ccc(O)cc2)NC(=O)[C@H](CC(C)C)NC(=O)[C@H](CO)NC(=O)[C@@H]2CSSC[C@H](NC(=O)[C@H](CCC(N)=O)NC(=O)[C@H](CCC(=O)O)NC(=O)[C@@H](NC(=O)[C@@H](NC(=O)CN)[C@@H](C)CC)C(C)C)C(=O)N[C@@H](CSSC[C@H](NC(=O)[C@H](CC(C)C)NC(=O)[C@H](Cc3c[nH]cn3)NC(=O)[C@H](CCC(N)=O)NC(=O)[C@H](CC(N)=O)NC(=O)[C@@H](NC(=O)[C@@H](N)Cc3ccccc3)C(C)C)C(=O)NCC(=O)N[C@@H](CO)C(=O)N[C@@H](Cc3c[nH]cn3)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](C(C)C)C(=O)N[C@@H](CCC(=O)O)C(=O)N[C@@H](C)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](Cc3ccc(O)cc3)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](C(C)C)C(=O)N1)C(=O)N[C@@H]([C@@H](C)O)C(=O)N[C@@H](CO)C(=O)N[C@@H]([C@@H](C)CC)C(=O)N2)[C@@H](C)O)C(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 226
Group description: Individually adjusted insulin detemir once daily + metformin at least 1500 mg/day
Eligibility criteria:
Inclusion Criteria:

Diagnosed with type 2 diabetes for at least 6 months
Stable treatment with a total daily dose of at least 1500 mg metformin or maximum tolerated dose (minimum 1000 mg) with or without one other OAD (sulphonylureas, meglitinides, thiazolidinediones or dipeptidyl peptidase-4 (DPP-4) inhibitors) for at least 3 months
Subject is insulin-naive (short-term insulin treatment of up to 14 days is allowed)
HbA1c (glycosylated haemoglobin) 7.0-9.0 % (both inclusive) by central laboratory analysis (one re-test within one week is allowed)
Body Mass Index (BMI) less than or equal to 35.0 kg/m^2

Exclusion Criteria:

Any contraindication to insulin detemir or insulin glargine according to the local labelling
Receipt of any investigational product within 4 weeks
Anticipated change of dose of any systemic treatment with products, which in the Investigator's opinion could interfere with glucose metabolism (e.g. systemic corticosteroids)
Clinically significant diseases which, in the Investigator's opinion may confound the results of the trial or pose additional risk in administering trial product
Any other condition that the Investigator feels would interfere with trial participation or evaluation of results
Intervention: ESLICARBAZEPINE ACETATE
Trial phase: Phase 3
SMILES: CC(=O)O[C@H]1Cc2ccccc2N(C(N)=O)c2ccccc21
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 274
Group description: Open-label treatment with eslicarbazepine acetate will be at doses between 800 and 2400 mg QD

Eslicarbazepine acetate: 800 to 2400 mg once daily (QD)
Eligibility criteria:
Subject Inclusion/Exclusion Criteria:

Subject who completed, exited, or discontinued for reasons other than safety from the 18-week treatment phase of Protocols 093-045 or 093-046 and are willing to continue participation in this study are eligible. Subject must have completed at least the first 3 weeks of the 18-week double-blind treatment period of Protocols 093-045 or 093-046 to be eligible.
Subject must give written informed consent prior to participation in the study. For subjects <18 years of age, the informed consent must be signed by the subject's parent or legal guardian, and, when appropriate and/or required by state or local law, minor subjects must give written informed assent prior to participation in the study. All subjects must sign privacy authorization form, if applicable. All females of child bearing potential (≤65 years of age) must also sign the "Women of Childbearing Potential" Addendum.
Subjects must, in the opinion of the Investigator (with consultation with Medical Monitor as appropriate), continue to potentially benefit from continued study participation and have no new medical conditions that would preclude study participation.
If female subject, must continue the accepted method of birth control defined in Protocols 093-045 or 093-046 for the duration of this study as well
Criterion for Continuation into the Post 1 year Part of Study:

For subjects to continue into the post 1 year part of the study, subjects must, in the opinion of the Investigator (with consultation with Medical Monitor, as appropriate), continue to potentially benefit from continued study participation and have no new medical conditions that would preclude study participation.
Intervention: Salicylhydroxamic Acid
Trial phase: Phase 2
SMILES: O=C(NO)c1ccccc1O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 25
Group description: Sham injection
Eligibility criteria:
Inclusion Criteria:

Male or female subjects aged > 50
Presence of focal vitreomacular adhesion measured by Optical Coherence Tomography (OCT).
Diagnosis of active primary or recurrent subfoveal CNV secondary to AMD, including those with predominantly classic, minimally classic or occult lesions with no classic component.
The total area of Choroidal Neovascularization (CNV) (including both classic and occult components) encompassed within the lesion must be > 50% of the total lesion area
The total lesion area must be < 12 disc areas
Subjects who have previously received at least three antiangiogenic injections(Lucentis® or Avastin®) in the study eye.
Subjects with visual acuity of 20/32 to 20/200 in the study eye
Written informed consent obtained from the subject prior to inclusion in the study

Exclusion Criteria:

Evidence of complete macular Posterior Vitreous Detachment (PVD) in the study eye on biomicroscopy, B-scan ultrasound or OCT prior to planned study drug injection
Subjects with vitreous haemorrhage which precludes either of the following: visualization of the posterior pole by visual inspection or adequate assessment of the macula by either OCT and/or fluorescein angiography in the study eye or other opacities precluding visualisation of the fundus.
Subjects who have previously received more than 9 antiangiogenic agent injections (whether Lucentis® or Avastin® or other anti-angiogenic agent) in the study eye
Subjects with history of rhegmatogenous retinal detachment or proliferative vitreoretinopathy (PVR) in the study eye
Subjects with high myopia (> 8D) or aphakia in the study eye
Subjects who have had ocular surgery in the study eye in the prior three months
Subjects who have had a vitrectomy in the study eye at any time.